[
 {
  "listed_as": "503B Outsourcing Facility One, LLC, West Palm Beach, FL",
  "name": "503B Outsourcing Facility One, LLC",
  "city": "West Palm Beach",
  "state": "FL",
  "phone": "1-754-265-4280",
  "initial_registration": "2/18/2025",
  "initial_registration_date": "2025-02-18",
  "recent_registration": "1/27/2026",
  "recent_registration_date": "2026-01-27",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
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  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "503b-outsourcing-facility-one-llc-west-palm-beach-fl",
  "aliases": [
   "503B Outsourcing Facility One, LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Florida Department of Health License Verification (Board of Pharmacy)",
   "url": "https://mqa-internet.doh.state.fl.us/MQASearchServices/Home",
   "kind": "license lookup"
  },
  "state_name": "Florida"
 },
 {
  "listed_as": "Ajenat Pharmaceuticals, LLC, Largo, FL",
  "name": "Ajenat Pharmaceuticals, LLC",
  "city": "Largo",
  "state": "FL",
  "phone": "1-727-506-1261",
  "initial_registration": "3/26/2025",
  "initial_registration_date": "2025-03-26",
  "recent_registration": "11/26/2025",
  "recent_registration_date": "2025-11-26",
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  "last_inspection_date": null,
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  "action_links": [],
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  "slug": "ajenat-pharmaceuticals-llc-largo-fl",
  "aliases": [
   "Ajenat Pharmaceuticals, LLC"
  ],
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  "actions_page_entries": [],
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   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Florida Department of Health License Verification (Board of Pharmacy)",
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   "kind": "license lookup"
  },
  "state_name": "Florida"
 },
 {
  "listed_as": "AnazaoHealth Corporation, Las Vegas, NV",
  "name": "AnazaoHealth Corporation",
  "city": "Las Vegas",
  "state": "NV",
  "phone": "800-995-4363",
  "initial_registration": "9/23/2014",
  "initial_registration_date": "2014-09-23",
  "recent_registration": "12/30/2025",
  "recent_registration_date": "2025-12-30",
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  "last_inspection_date": "2025-08-08",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/188525/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "anazaohealth-corporation-las-vegas-nv",
  "aliases": [
   "AnazaoHealth Corporation"
  ],
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   {
    "heading": "Anazaohealth Corporation, Las Vegas, NV - 503B Facility",
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    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "93500",
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    "match_reason": "Exact name, city and state match",
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    "date": "2023-11-22",
    "report_date": "2024-01-03",
    "classification_date": "2023-12-26",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Particulate Matter."
    ],
    "recall_numbers": [
     "D-0203-2024",
     "D-0204-2024"
    ],
    "products": [
     "Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealth, 7465 W. Sunset Road, Las Vegas, NV, NDC 72682-8721-3.",
     "B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML Sterile Multiple-Dose Vial, Rx only, AnazaoHealth, 7465 W Sunset Rd #1200, Las Vegas, NV 89113, NDC 72682-2230-3"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293500%22&limit=100",
    "classification": "Class II",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "70465",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "AnazaoHealth Corporation",
    "firm_city": "Las Vegas",
    "firm_state": "NV",
    "date": "2015-01-26",
    "report_date": "2015-02-18",
    "classification_date": "2015-02-09",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source."
    ],
    "recall_numbers": [
     "D0384-2015"
    ],
    "products": [
     "Compounded Plaquex, intravenous injection, 50 ML vial.   Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2270465%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
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   }
  ],
  "timeline": [
   {
    "type": "inspection",
    "date": "2025-08-08",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/188525/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-08-08",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/188525/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2024-09-23",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 09/23/2024 (PDF - 1 MB)",
    "url": "https://www.fda.gov/media/185396/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Anazaohealth Corporation, Las Vegas, NV - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "93500",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "AnazaoHealth Corporation",
    "firm_city": "Las Vegas",
    "firm_state": "NV",
    "date": "2023-11-22",
    "report_date": "2024-01-03",
    "classification_date": "2023-12-26",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Particulate Matter."
    ],
    "recall_numbers": [
     "D-0203-2024",
     "D-0204-2024"
    ],
    "products": [
     "Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealth, 7465 W. Sunset Road, Las Vegas, NV, NDC 72682-8721-3.",
     "B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML Sterile Multiple-Dose Vial, Rx only, AnazaoHealth, 7465 W Sunset Rd #1200, Las Vegas, NV 89113, NDC 72682-2230-3"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293500%22&limit=100",
    "classification": "Class II",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "regulatory_meeting",
    "date": "2023-05-02",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Regulatory Meeting Held 05/02/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Anazaohealth Corporation, Las Vegas, NV - 503B Facility"
   },
   {
    "type": "483",
    "date": "2022-07-29",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 07/29/2022 (PDF - 853 KB)",
    "url": "https://www.fda.gov/media/163365/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Anazaohealth Corporation, Las Vegas, NV - 503B Facility"
   },
   {
    "type": "warning_letter",
    "date": "2021-08-18",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter (08/18/2021)",
    "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/anazaohealth-corporation-613214-08182021",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Anazaohealth Corporation, Las Vegas, NV - 503B Facility"
   },
   {
    "type": "483",
    "date": "2019-09-19",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 09/19/2019 (PDF - 501 KB)",
    "url": "https://www.fda.gov/media/132898/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Anazaohealth Corporation, Las Vegas, NV - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "70465",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "AnazaoHealth Corporation",
    "firm_city": "Las Vegas",
    "firm_state": "NV",
    "date": "2015-01-26",
    "report_date": "2015-02-18",
    "classification_date": "2015-02-09",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source."
    ],
    "recall_numbers": [
     "D0384-2015"
    ],
    "products": [
     "Compounded Plaquex, intravenous injection, 50 ML vial.   Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2270465%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "counts": {
   "form483": 4,
   "warning_letters": 1,
   "recalls": 2,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Nevada State Board of Pharmacy",
   "url": "https://bop.nv.gov/",
   "kind": "board site"
  },
  "state_name": "Nevada"
 },
 {
  "listed_as": "Annovex Pharma, Inc., Lorton, VA",
  "name": "Annovex Pharma, Inc.",
  "city": "Lorton",
  "state": "VA",
  "phone": "1-571-642-5262",
  "initial_registration": "10/14/2021",
  "initial_registration_date": "2021-10-14",
  "recent_registration": "2/13/2026",
  "recent_registration_date": "2026-02-13",
  "last_inspection": "6/3/2026",
  "last_inspection_date": "2026-06-03",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/193728/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "annovex-pharma-inc-lorton-va",
  "aliases": [
   "Annovex Pharma, Inc."
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Annovex Pharma, Inc., Lorton, VA - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "483",
    "date": "2026-06-18",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Amended 483 Issued 06/18/2026 (PDF - 618 KB)",
    "url": "https://www.fda.gov/media/193728/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Annovex Pharma, Inc., Lorton, VA - 503B Facility"
   },
   {
    "type": "inspection",
    "date": "2026-06-03",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/193728/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-06-03",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/193728/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "warning_letter",
    "date": "2025-03-05",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter Issued 03/05/2025",
    "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/annovex-pharma-inc-698115-03052025",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Annovex Pharma, Inc., Lorton, VA - 503B Facility"
   },
   {
    "type": "483",
    "date": "2024-09-06",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 09/06/2024 (PDF - 1 KB)",
    "url": "https://www.fda.gov/media/182397/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Annovex Pharma, Inc., Lorton, VA - 503B Facility"
   }
  ],
  "counts": {
   "form483": 3,
   "warning_letters": 1,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Virginia Department of Health Professions License Lookup (Board of Pharmacy)",
   "url": "https://dhp.virginiainteractive.org/Lookup/Index",
   "kind": "license lookup"
  },
  "state_name": "Virginia"
 },
 {
  "listed_as": "Apertus Compounding, LLC, Maryland Heights, MO",
  "name": "Apertus Compounding, LLC",
  "city": "Maryland Heights",
  "state": "MO",
  "phone": "1-314-607-0432",
  "initial_registration": "11/26/2025",
  "initial_registration_date": "2025-11-26",
  "recent_registration": "11/26/2025",
  "recent_registration_date": "2025-11-26",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "apertus-compounding-llc-maryland-heights-mo",
  "aliases": [
   "Apertus Compounding, LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Missouri Division of Professional Registration Licensee Search (Board of Pharmacy)",
   "url": "https://pr.mo.gov/licensee-search.asp",
   "kind": "license lookup"
  },
  "state_name": "Missouri"
 },
 {
  "listed_as": "Apocus, Inc., San Antonio, TX",
  "name": "Apocus, Inc.",
  "city": "San Antonio",
  "state": "TX",
  "phone": "1-214-797-7172",
  "initial_registration": "10/17/2023",
  "initial_registration_date": "2023-10-17",
  "recent_registration": "1/1/2026",
  "recent_registration_date": "2026-01-01",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "apocus-inc-san-antonio-tx",
  "aliases": [
   "Apocus, Inc."
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Texas State Board of Pharmacy License Verification",
   "url": "https://www.pharmacy.texas.gov/dbsearch/phy_search.asp",
   "kind": "license lookup"
  },
  "state_name": "Texas"
 },
 {
  "listed_as": "Apollo Care, Columbia, MO",
  "name": "Apollo Care",
  "city": "Columbia",
  "state": "MO",
  "phone": "573-441-8900",
  "initial_registration": "9/14/2017",
  "initial_registration_date": "2017-09-14",
  "recent_registration": "12/24/2025",
  "recent_registration_date": "2025-12-24",
  "last_inspection": "7/28/2026",
  "last_inspection_date": "2026-07-28",
  "form483_issued": "Yes",
  "form483_links": [],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "apollo-care-columbia-mo",
  "aliases": [
   "Apollo Care"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Apollo Care LLC, Columbia, MO - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "99505",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Apollo Care, LLC",
    "firm_city": "Columbia",
    "firm_state": "MO",
    "date": "2026-07-29",
    "report_date": "2026-08-19",
    "classification_date": "2026-08-07",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material"
    ],
    "recall_numbers": [
     "D-0747-2026",
     "D-0748-2026",
     "D-0749-2026",
     "D-0750-2026",
     "D-0751-2026",
     "D-0752-2026",
     "D-0753-2026",
     "D-0754-2026",
     "D-0755-2026",
     "D-0756-2026",
     "D-0757-2026"
    ],
    "products": [
     "SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-01",
     "SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05",
     "SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02",
     "SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-02",
     "SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-821-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2299505%22&limit=100",
    "classification": "Class II",
    "product_count": 11,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "96754",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Apollo Care, LLC",
    "firm_city": "Columbia",
    "firm_state": "MO",
    "date": "2025-04-15",
    "report_date": "2025-05-14",
    "classification_date": "2025-05-06",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0409-2025"
    ],
    "products": [
     "FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-9"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296754%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "92348",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Apollo Care, LLC",
    "firm_city": "Columbia",
    "firm_state": "MO",
    "date": "2023-05-02",
    "report_date": "2023-05-24",
    "classification_date": "2023-05-18",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0632-2023",
     "D-0633-2023",
     "D-0634-2023",
     "D-0635-2023",
     "D-0636-2023",
     "D-0637-2023",
     "D-0638-2023",
     "D-0639-2023",
     "D-0640-2023",
     "D-0641-2023",
     "D-0642-2023",
     "D-0643-2023",
     "D-0644-2023",
     "D-0645-2023",
     "D-0646-2023",
     "D-0647-2023"
    ],
    "products": [
     "FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25",
     "Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-050-05",
     "VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25",
     "Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-500-25",
     "VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-284-25"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2292348%22&limit=100",
    "classification": "Class II",
    "product_count": 16,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "91674",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Apollo Care",
    "firm_city": "Columbia",
    "firm_state": "MO",
    "date": "2023-02-08",
    "report_date": "2023-04-05",
    "classification_date": "2023-03-24",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of assurance of sterility: Suspected microbial growth present on external label packaging."
    ],
    "recall_numbers": [
     "D-0487-2023"
    ],
    "products": [
     "Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291674%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "89011",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Apollo Care",
    "firm_city": "Columbia",
    "firm_state": "MO",
    "date": "2021-10-28",
    "report_date": "2021-12-15",
    "classification_date": "2021-12-08",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Crystallization: Product appears to be turbid."
    ],
    "recall_numbers": [
     "D-0277-2022"
    ],
    "products": [
     "VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous Use Only), 260 mL per bag, Rx Only, This is a Compounded Drug, Hospital/Office Use Only, Apollo Care 3801 Mojave Ct, Suite 101, Columbia, MO 65202, NDC 71170-25"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2289011%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "79517",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Apollo Care",
    "firm_city": "Columbia",
    "firm_state": "MO",
    "date": "2018-03-07",
    "report_date": "2018-04-04",
    "classification_date": "2018-03-29",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported."
    ],
    "recall_numbers": [
     "D-0614-2018",
     "D-0615-2018"
    ],
    "products": [
     "Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.",
     "Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2279517%22&limit=100",
    "classification": "Class II",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "79331",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Apollo Care",
    "firm_city": "Columbia",
    "firm_state": "MO",
    "date": "2018-02-15",
    "report_date": "2018-03-14",
    "classification_date": "2018-03-06",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported."
    ],
    "recall_numbers": [
     "D-0579-2018",
     "D-0580-2018"
    ],
    "products": [
     "Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202,  NDC 71170-254-25.",
     "Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202,  NDC 71170-264-25."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2279331%22&limit=100",
    "classification": "Class II",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "recall",
    "event_id": "99505",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Apollo Care, LLC",
    "firm_city": "Columbia",
    "firm_state": "MO",
    "date": "2026-07-29",
    "report_date": "2026-08-19",
    "classification_date": "2026-08-07",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material"
    ],
    "recall_numbers": [
     "D-0747-2026",
     "D-0748-2026",
     "D-0749-2026",
     "D-0750-2026",
     "D-0751-2026",
     "D-0752-2026",
     "D-0753-2026",
     "D-0754-2026",
     "D-0755-2026",
     "D-0756-2026",
     "D-0757-2026"
    ],
    "products": [
     "SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-01",
     "SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05",
     "SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02",
     "SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-02",
     "SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-821-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2299505%22&limit=100",
    "classification": "Class II",
    "product_count": 11,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "inspection",
    "date": "2026-07-28",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-07-28",
    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page (\"483 Issued 07/28/2026 (PDF - 1.60MB)\")",
    "url": "https://www.fda.gov/media/194617/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "warning_letter",
    "date": "2026-02-02",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter (02/02/2026)",
    "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apollo-care-llc-715955-02022026",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Apollo Care LLC, Columbia, MO - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "96754",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Apollo Care, LLC",
    "firm_city": "Columbia",
    "firm_state": "MO",
    "date": "2025-04-15",
    "report_date": "2025-05-14",
    "classification_date": "2025-05-06",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0409-2025"
    ],
    "products": [
     "FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-9"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296754%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2025-03-27",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 03/27/2025 (PDF - 2 MB)",
    "url": "https://www.fda.gov/media/187221/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Apollo Care LLC, Columbia, MO - 503B Facility"
   },
   {
    "type": "regulatory_meeting",
    "date": "2023-11-27",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Regulatory Meeting Held 11/27/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Apollo Care LLC, Columbia, MO - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "92348",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Apollo Care, LLC",
    "firm_city": "Columbia",
    "firm_state": "MO",
    "date": "2023-05-02",
    "report_date": "2023-05-24",
    "classification_date": "2023-05-18",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0632-2023",
     "D-0633-2023",
     "D-0634-2023",
     "D-0635-2023",
     "D-0636-2023",
     "D-0637-2023",
     "D-0638-2023",
     "D-0639-2023",
     "D-0640-2023",
     "D-0641-2023",
     "D-0642-2023",
     "D-0643-2023",
     "D-0644-2023",
     "D-0645-2023",
     "D-0646-2023",
     "D-0647-2023"
    ],
    "products": [
     "FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-950-25",
     "Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-050-05",
     "VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-184-25",
     "Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-500-25",
     "VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-284-25"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2292348%22&limit=100",
    "classification": "Class II",
    "product_count": 16,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2023-04-05",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 04/05/2023 (PDF - 2 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/170139/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Apollo Care LLC, Columbia, MO - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "91674",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Apollo Care",
    "firm_city": "Columbia",
    "firm_state": "MO",
    "date": "2023-02-08",
    "report_date": "2023-04-05",
    "classification_date": "2023-03-24",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of assurance of sterility: Suspected microbial growth present on external label packaging."
    ],
    "recall_numbers": [
     "D-0487-2023"
    ],
    "products": [
     "Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291674%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "89011",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Apollo Care",
    "firm_city": "Columbia",
    "firm_state": "MO",
    "date": "2021-10-28",
    "report_date": "2021-12-15",
    "classification_date": "2021-12-08",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Crystallization: Product appears to be turbid."
    ],
    "recall_numbers": [
     "D-0277-2022"
    ],
    "products": [
     "VANComycin 1g added to 250mL of 0.9% Sodium Chloride (Injection for Intravenous Use Only), 260 mL per bag, Rx Only, This is a Compounded Drug, Hospital/Office Use Only, Apollo Care 3801 Mojave Ct, Suite 101, Columbia, MO 65202, NDC 71170-25"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2289011%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2021-09-08",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 09/8/2021 (PDF - 2 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/158299/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Apollo Care LLC, Columbia, MO - 503B Facility"
   },
   {
    "type": "warning_letter",
    "date": "2019-03-20",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter (03/20/2019)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apollo-care-574756-03202019",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Apollo Care LLC, Columbia, MO - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "79517",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Apollo Care",
    "firm_city": "Columbia",
    "firm_state": "MO",
    "date": "2018-03-07",
    "report_date": "2018-04-04",
    "classification_date": "2018-03-29",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported."
    ],
    "recall_numbers": [
     "D-0614-2018",
     "D-0615-2018"
    ],
    "products": [
     "Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.",
     "Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2279517%22&limit=100",
    "classification": "Class II",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "79331",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Apollo Care",
    "firm_city": "Columbia",
    "firm_state": "MO",
    "date": "2018-02-15",
    "report_date": "2018-03-14",
    "classification_date": "2018-03-06",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported."
    ],
    "recall_numbers": [
     "D-0579-2018",
     "D-0580-2018"
    ],
    "products": [
     "Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202,  NDC 71170-254-25.",
     "Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202,  NDC 71170-264-25."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2279331%22&limit=100",
    "classification": "Class II",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   }
  ],
  "counts": {
   "form483": 4,
   "warning_letters": 2,
   "recalls": 7,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Missouri Division of Professional Registration Licensee Search (Board of Pharmacy)",
   "url": "https://pr.mo.gov/licensee-search.asp",
   "kind": "license lookup"
  },
  "state_name": "Missouri"
 },
 {
  "listed_as": "Apothecary Pharma, LLC, Cary, NC",
  "name": "Apothecary Pharma, LLC",
  "city": "Cary",
  "state": "NC",
  "phone": "1-919-760-5478",
  "initial_registration": "9/7/2024",
  "initial_registration_date": "2024-09-07",
  "recent_registration": "1/6/2026",
  "recent_registration_date": "2026-01-06",
  "last_inspection": "9/2/2026",
  "last_inspection_date": "2026-09-02",
  "form483_issued": "Yes",
  "form483_links": [],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "apothecary-pharma-llc-cary-nc",
  "aliases": [
   "Apothecary Pharma, LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Apothecary Pharma LLC, Cary, NC - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-09-02",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-09-02",
    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table (no document link published there)",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "warning_letter",
    "date": "2025-12-01",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter Issued 12/01/2025",
    "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apothecary-pharma-llc-717972-12012025",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Apothecary Pharma LLC, Cary, NC - 503B Facility"
   },
   {
    "type": "483",
    "date": "2025-05-15",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 05/15/2025",
    "url": "https://www.fda.gov/media/186741/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Apothecary Pharma LLC, Cary, NC - 503B Facility"
   }
  ],
  "counts": {
   "form483": 2,
   "warning_letters": 1,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "North Carolina Board of Pharmacy",
   "url": "https://www.ncbop.org/",
   "kind": "board site"
  },
  "state_name": "North Carolina"
 },
 {
  "listed_as": "Arc Compounding Pharmacy, LLC, Waco, TX",
  "name": "Arc Compounding Pharmacy, LLC",
  "city": "Waco",
  "state": "TX",
  "phone": "1-512-665-6911",
  "initial_registration": "6/22/2024",
  "initial_registration_date": "2024-06-22",
  "recent_registration": "2/20/2026",
  "recent_registration_date": "2026-02-20",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "arc-compounding-pharmacy-llc-waco-tx",
  "aliases": [
   "Arc Compounding Pharmacy, LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Texas State Board of Pharmacy License Verification",
   "url": "https://www.pharmacy.texas.gov/dbsearch/phy_search.asp",
   "kind": "license lookup"
  },
  "state_name": "Texas"
 },
 {
  "listed_as": "Aspire Compounding Pharmacy, Sugar Land, TX",
  "name": "Aspire Compounding Pharmacy",
  "city": "Sugar Land",
  "state": "TX",
  "phone": "1-281-501-0511",
  "initial_registration": "3/21/2025",
  "initial_registration_date": "2025-03-21",
  "recent_registration": "2/24/2026",
  "recent_registration_date": "2026-02-24",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "aspire-compounding-pharmacy-sugar-land-tx",
  "aliases": [
   "Aspire Compounding Pharmacy"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Texas State Board of Pharmacy License Verification",
   "url": "https://www.pharmacy.texas.gov/dbsearch/phy_search.asp",
   "kind": "license lookup"
  },
  "state_name": "Texas"
 },
 {
  "listed_as": "Assure Infusions, Inc., Bartow, FL",
  "name": "Assure Infusions, Inc.",
  "city": "Bartow",
  "state": "FL",
  "phone": "1-863-663-4187",
  "initial_registration": "11/22/2024",
  "initial_registration_date": "2024-11-22",
  "recent_registration": "12/5/2025",
  "recent_registration_date": "2025-12-05",
  "last_inspection": "9/17/2026",
  "last_inspection_date": "2026-09-17",
  "form483_issued": "Yes",
  "form483_links": [],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "No",
  "slug": "assure-infusions-inc-bartow-fl",
  "aliases": [
   "Assure Infusions, Inc."
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-09-17",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-09-17",
    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table (no document link published there)",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   }
  ],
  "counts": {
   "form483": 1,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Florida Department of Health License Verification (Board of Pharmacy)",
   "url": "https://mqa-internet.doh.state.fl.us/MQASearchServices/Home",
   "kind": "license lookup"
  },
  "state_name": "Florida"
 },
 {
  "listed_as": "Atilar Pharma Corporation, Houston, TX",
  "name": "Atilar Pharma Corporation",
  "city": "Houston",
  "state": "TX",
  "phone": "1-713-992-3884",
  "initial_registration": "2/20/2025",
  "initial_registration_date": "2025-02-20",
  "recent_registration": "12/24/2025",
  "recent_registration_date": "2025-12-24",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "atilar-pharma-corporation-houston-tx",
  "aliases": [
   "Atilar Pharma Corporation"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Texas State Board of Pharmacy License Verification",
   "url": "https://www.pharmacy.texas.gov/dbsearch/phy_search.asp",
   "kind": "license lookup"
  },
  "state_name": "Texas"
 },
 {
  "listed_as": "Aveva Drug Delivery Systems, Inc, Tamarac, FL",
  "name": "Aveva Drug Delivery Systems, Inc",
  "city": "Tamarac",
  "state": "FL",
  "phone": "1-954-218-1570",
  "initial_registration": "11/4/2024",
  "initial_registration_date": "2024-11-04",
  "recent_registration": "11/25/2025",
  "recent_registration_date": "2025-11-25",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "aveva-drug-delivery-systems-inc-tamarac-fl",
  "aliases": [
   "Aveva Drug Delivery Systems, Inc"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [
   {
    "type": "recall",
    "event_id": "98972",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Miramar, FL); may be another site of the same company",
    "recalling_firm": "AVEVA Drug Delivery Systems, Inc.",
    "firm_city": "Miramar",
    "firm_state": "FL",
    "date": "2026-05-14",
    "report_date": "2026-06-03",
    "classification_date": "2026-05-26",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units."
    ],
    "recall_numbers": [
     "D-0550-2026"
    ],
    "products": [
     "Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2298972%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "91712",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Miramar, FL); may be another site of the same company",
    "recalling_firm": "AVEVA Drug Delivery Systems, Inc.",
    "firm_city": "Miramar",
    "firm_state": "FL",
    "date": "2023-02-15",
    "report_date": "2023-03-22",
    "classification_date": "2023-03-14",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint."
    ],
    "recall_numbers": [
     "D-0465-2023",
     "D-0466-2023"
    ],
    "products": [
     "Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC  ",
     "Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 6"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291712%22&limit=100",
    "classification": "Class III",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "recall",
    "event_id": "98972",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Miramar, FL); may be another site of the same company",
    "recalling_firm": "AVEVA Drug Delivery Systems, Inc.",
    "firm_city": "Miramar",
    "firm_state": "FL",
    "date": "2026-05-14",
    "report_date": "2026-06-03",
    "classification_date": "2026-05-26",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units."
    ],
    "recall_numbers": [
     "D-0550-2026"
    ],
    "products": [
     "Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2298972%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "91712",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Miramar, FL); may be another site of the same company",
    "recalling_firm": "AVEVA Drug Delivery Systems, Inc.",
    "firm_city": "Miramar",
    "firm_state": "FL",
    "date": "2023-02-15",
    "report_date": "2023-03-22",
    "classification_date": "2023-03-14",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint."
    ],
    "recall_numbers": [
     "D-0465-2023",
     "D-0466-2023"
    ],
    "products": [
     "Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC  ",
     "Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 6"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291712%22&limit=100",
    "classification": "Class III",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   }
  ],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 2
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Florida Department of Health License Verification (Board of Pharmacy)",
   "url": "https://mqa-internet.doh.state.fl.us/MQASearchServices/Home",
   "kind": "license lookup"
  },
  "state_name": "Florida"
 },
 {
  "listed_as": "BayCare Integrated Service Center, LLC dba BayCare Central Pharmacy, Temple Terrace, FL",
  "name": "BayCare Integrated Service Center, LLC dba BayCare Central Pharmacy",
  "city": "Temple Terrace",
  "state": "FL",
  "phone": "1-813-901-6376",
  "initial_registration": "6/4/2019",
  "initial_registration_date": "2019-06-04",
  "recent_registration": "2/5/2026",
  "recent_registration_date": "2026-02-05",
  "last_inspection": "3/12/2026",
  "last_inspection_date": "2026-03-12",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/192067/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "FMD-145 Letter Issued 9/18/2023",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "No",
  "slug": "baycare-integrated-service-center-llc-dba-baycare-central-pharmacy-temple-terrace-fl",
  "aliases": [
   "BayCare Integrated Service Center, LLC",
   "BayCare Central Pharmacy"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Baycare Integrated Service Center, LLC dba BayCare Central Pharmacy, Temple Terrace, FL - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-03-12",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/192067/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-03-12",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/192067/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "fmd145_letter",
    "date": "2023-09-18",
    "match": "table",
    "text": "FMD-145 Letter Issued 9/18/2023",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "fmd145_letter",
    "date": "2023-09-15",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 09/15/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Baycare Integrated Service Center, LLC dba BayCare Central Pharmacy, Temple Terrace, FL - 503B Facility"
   },
   {
    "type": "483",
    "date": "2023-06-02",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 06/02/2023 (PDF - 194 KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/170879/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Baycare Integrated Service Center, LLC dba BayCare Central Pharmacy, Temple Terrace, FL - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2022-04-04",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 04/04/2022",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Baycare Integrated Service Center, LLC dba BayCare Central Pharmacy, Temple Terrace, FL - 503B Facility"
   },
   {
    "type": "untitled_letter",
    "date": "2021-09-13",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Untitled Letter Issued 09/13/2021 (PDF - 2 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/180706/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Baycare Integrated Service Center, LLC dba BayCare Central Pharmacy, Temple Terrace, FL - 503B Facility"
   },
   {
    "type": "483",
    "date": "2019-12-10",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 12/10/2019 (PDF - 951 KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/152762/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Baycare Integrated Service Center, LLC dba BayCare Central Pharmacy, Temple Terrace, FL - 503B Facility"
   }
  ],
  "counts": {
   "form483": 3,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Florida Department of Health License Verification (Board of Pharmacy)",
   "url": "https://mqa-internet.doh.state.fl.us/MQASearchServices/Home",
   "kind": "license lookup"
  },
  "state_name": "Florida"
 },
 {
  "listed_as": "Bennett Pharmaceuticals of America LLC, Hudson, WI",
  "name": "Bennett Pharmaceuticals of America LLC",
  "city": "Hudson",
  "state": "WI",
  "phone": "952-381-9027",
  "initial_registration": "4/19/2022",
  "initial_registration_date": "2022-04-19",
  "recent_registration": "1/21/2026",
  "recent_registration_date": "2026-01-21",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "bennett-pharmaceuticals-of-america-llc-hudson-wi",
  "aliases": [
   "Bennett Pharmaceuticals of America LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Wisconsin DSPS License Search (Pharmacy Examining Board)",
   "url": "https://licensesearch.wi.gov/",
   "kind": "license lookup"
  },
  "state_name": "Wisconsin"
 },
 {
  "listed_as": "Bespoke Pharmaceutical, LLC, Las Vegas, NV",
  "name": "Bespoke Pharmaceutical, LLC",
  "city": "Las Vegas",
  "state": "NV",
  "phone": "1-857-995-7999",
  "initial_registration": "3/7/2026",
  "initial_registration_date": "2026-03-07",
  "recent_registration": "3/7/2026",
  "recent_registration_date": "2026-03-07",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "bespoke-pharmaceutical-llc-las-vegas-nv",
  "aliases": [
   "Bespoke Pharmaceutical, LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Nevada State Board of Pharmacy",
   "url": "https://bop.nv.gov/",
   "kind": "board site"
  },
  "state_name": "Nevada"
 },
 {
  "listed_as": "BPI Labs LLC, Largo, FL",
  "name": "BPI Labs LLC",
  "city": "Largo",
  "state": "FL",
  "phone": "1-727-471-0850",
  "initial_registration": "3/4/2019",
  "initial_registration_date": "2019-03-04",
  "recent_registration": "12/3/2025",
  "recent_registration_date": "2025-12-03",
  "last_inspection": "4/17/2026",
  "last_inspection_date": "2026-04-17",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/192439/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "bpi-labs-llc-largo-fl",
  "aliases": [
   "BPI Labs LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "BPI Labs, LLC, Largo, FL - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-04-17",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/192439/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-04-17",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/192439/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "fmd145_letter",
    "date": "2025-07-28",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 07/28/2025",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "BPI Labs, LLC, Largo, FL - 503B Facility"
   },
   {
    "type": "483",
    "date": "2025-02-21",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 02/21/2025 (PDF - 338 KB)",
    "url": "https://www.fda.gov/media/185637/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "BPI Labs, LLC, Largo, FL - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2021-09-01",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 09/01/2021",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "BPI Labs, LLC, Largo, FL - 503B Facility"
   },
   {
    "type": "483",
    "date": "2021-04-30",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 04/30/2021 (PDF - 2 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/158757/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "BPI Labs, LLC, Largo, FL - 503B Facility"
   }
  ],
  "counts": {
   "form483": 3,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Florida Department of Health License Verification (Board of Pharmacy)",
   "url": "https://mqa-internet.doh.state.fl.us/MQASearchServices/Home",
   "kind": "license lookup"
  },
  "state_name": "Florida"
 },
 {
  "listed_as": "Bravado Pharmaceuticals, LLC, Lutz, FL",
  "name": "Bravado Pharmaceuticals, LLC",
  "city": "Lutz",
  "state": "FL",
  "phone": "1-813-991-4100",
  "initial_registration": "2/28/2025",
  "initial_registration_date": "2025-02-28",
  "recent_registration": "1/10/2026",
  "recent_registration_date": "2026-01-10",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "bravado-pharmaceuticals-llc-lutz-fl",
  "aliases": [
   "Bravado Pharmaceuticals, LLC"
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  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Florida Department of Health License Verification (Board of Pharmacy)",
   "url": "https://mqa-internet.doh.state.fl.us/MQASearchServices/Home",
   "kind": "license lookup"
  },
  "state_name": "Florida"
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 {
  "listed_as": "Brookfield Medical/Surgical Supply, Inc., Brookfield, CT",
  "name": "Brookfield Medical/Surgical Supply, Inc.",
  "city": "Brookfield",
  "state": "CT",
  "phone": "203-775-0862",
  "initial_registration": "1/12/2015",
  "initial_registration_date": "2015-01-12",
  "recent_registration": "12/30/2025",
  "recent_registration_date": "2025-12-30",
  "last_inspection": "7/10/2026",
  "last_inspection_date": "2026-07-10",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/179540/download?attachment"
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  ],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "brookfield-medical-surgical-supply-inc-brookfield-ct",
  "aliases": [
   "Brookfield Medical/Surgical Supply, Inc."
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  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Brookfield Medical/Surgical Supply, Inc., Brookfield, CT - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-07-10",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/179540/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-07-10",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/179540/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "fmd145_letter",
    "date": "2025-02-13",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 02/13/2025",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Brookfield Medical/Surgical Supply, Inc., Brookfield, CT - 503B Facility"
   },
   {
    "type": "untitled_letter",
    "date": "2024-09-27",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Untitled Letter Issued 09/27/2024 (PDF - 212 KB)",
    "url": "https://www.fda.gov/media/183392/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Brookfield Medical/Surgical Supply, Inc., Brookfield, CT - 503B Facility"
   },
   {
    "type": "483",
    "date": "2024-05-10",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 05/10/2024 (PDF - 991 KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/179540/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Brookfield Medical/Surgical Supply, Inc., Brookfield, CT - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2023-02-06",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 02/06/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Brookfield Medical/Surgical Supply, Inc., Brookfield, CT - 503B Facility"
   },
   {
    "type": "483",
    "date": "2022-04-04",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 04/04/2022 (PDF - 5 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/161532/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Brookfield Medical/Surgical Supply, Inc., Brookfield, CT - 503B Facility"
   }
  ],
  "counts": {
   "form483": 3,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Connecticut eLicense Lookup (Commission of Pharmacy)",
   "url": "https://www.elicense.ct.gov/Lookup/LicenseLookup.aspx",
   "kind": "license lookup"
  },
  "state_name": "Connecticut"
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 {
  "listed_as": "BSO LLC, Golden, CO",
  "name": "BSO LLC",
  "city": "Golden",
  "state": "CO",
  "phone": "608-221-7800 Ext 1113",
  "initial_registration": "1/24/2024",
  "initial_registration_date": "2024-01-24",
  "recent_registration": "11/25/2025",
  "recent_registration_date": "2025-11-25",
  "last_inspection": "6/27/2025",
  "last_inspection_date": "2025-06-27",
  "form483_issued": "483",
  "form483_links": [
   {
    "text": "483",
    "url": "https://www.fda.gov/media/188193/download?attachment"
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  ],
  "recall_conducted": "N/A",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "bso-llc-golden-co",
  "aliases": [
   "BSO LLC"
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  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "BSO LLC (dba Belmar Select Outsourcing), Golden, CO - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   },
   {
    "heading": "BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO - 503B Facility",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Lakewood, CO); may be another site of the same company"
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  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "96792",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Lakewood, CO); may be another site of the same company",
    "recalling_firm": "BSO LLC",
    "firm_city": "Lakewood",
    "firm_state": "CO",
    "date": "2025-04-28",
    "report_date": "2025-05-14",
    "classification_date": "2025-05-06",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Particulate Matter: Glass particles were found in pellet vials."
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    "recall_numbers": [
     "D-0412-2025",
     "D-0413-2025",
     "D-0414-2025",
     "D-0415-2025",
     "D-0416-2025"
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    "products": [
     "TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0101-0",
     "TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0121-01",
     "TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0122-0",
     "TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-",
     "TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0125-0"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296792%22&limit=100",
    "classification": "Class II",
    "product_count": 5,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "483",
    "date": "2025-07-16",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Lakewood, CO); may be another site of the same company",
    "text": "Amended 483 Issued 07/16/2025 (PDF - 3 MB)",
    "url": "https://www.fda.gov/media/188200/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO - 503B Facility"
   },
   {
    "type": "inspection",
    "date": "2025-06-27",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: 483",
    "url": "https://www.fda.gov/media/188193/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-06-27",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/188193/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "recall",
    "event_id": "96792",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Lakewood, CO); may be another site of the same company",
    "recalling_firm": "BSO LLC",
    "firm_city": "Lakewood",
    "firm_state": "CO",
    "date": "2025-04-28",
    "report_date": "2025-05-14",
    "classification_date": "2025-05-06",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Particulate Matter: Glass particles were found in pellet vials."
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    "recall_numbers": [
     "D-0412-2025",
     "D-0413-2025",
     "D-0414-2025",
     "D-0415-2025",
     "D-0416-2025"
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    "products": [
     "TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0101-0",
     "TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0121-01",
     "TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0122-0",
     "TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-",
     "TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0125-0"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296792%22&limit=100",
    "classification": "Class II",
    "product_count": 5,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2024-07-03",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Lakewood, CO); may be another site of the same company",
    "text": "483 Issued 07/03/2024 (PDF - 1 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/182398/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2021-09-15",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Lakewood, CO); may be another site of the same company",
    "text": "FMD-145 Letter Issued 09/15/2021",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO - 503B Facility"
   },
   {
    "type": "483",
    "date": "2021-03-11",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Lakewood, CO); may be another site of the same company",
    "text": "483 Issued 03/11/2021 (PDF - 1 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/149780/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2020-06-22",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Lakewood, CO); may be another site of the same company",
    "text": "FMD-145 Letter Issued 6/22/2020 (PFD - 60 KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/140379/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO - 503B Facility"
   },
   {
    "type": "483",
    "date": "2019-09-20",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Lakewood, CO); may be another site of the same company",
    "text": "483 Issued 09/20/2019 (PDF - 265 KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/132339/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO - 503B Facility"
   },
   {
    "type": "untitled_letter",
    "date": "2019-01-10",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Lakewood, CO); may be another site of the same company",
    "text": "Untitled Letter Issued 01/10/2019 (PDF - 698 KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/139424/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO - 503B Facility"
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  ],
  "counts": {
   "form483": 1,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 8
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Colorado DORA License Lookup (State Board of Pharmacy)",
   "url": "https://apps2.colorado.gov/dora/licensing/Lookup/LicenseLookup.aspx",
   "kind": "license lookup"
  },
  "state_name": "Colorado"
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 {
  "listed_as": "BSO LLC, Lakewood, CO",
  "name": "BSO LLC",
  "city": "Lakewood",
  "state": "CO",
  "phone": "608-221-7800 Ext 1113",
  "initial_registration": "11/24/2015",
  "initial_registration_date": "2015-11-24",
  "recent_registration": "11/26/2025",
  "recent_registration_date": "2025-11-26",
  "last_inspection": "7/16/2025",
  "last_inspection_date": "2025-07-16",
  "form483_issued": "483",
  "form483_links": [
   {
    "text": "483",
    "url": "https://www.fda.gov/media/188200/download?attachment"
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  ],
  "recall_conducted": "No",
  "action_last_inspection": "Regulatory Meeting Held 3/3/2026",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "bso-llc-lakewood-co",
  "aliases": [
   "BSO LLC"
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  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "BSO LLC (dba Belmar Select Outsourcing), Golden, CO - 503B Facility",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Golden, CO); may be another site of the same company"
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   {
    "heading": "BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
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  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "96792",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "BSO LLC",
    "firm_city": "Lakewood",
    "firm_state": "CO",
    "date": "2025-04-28",
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    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
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    "recall_numbers": [
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     "D-0413-2025",
     "D-0414-2025",
     "D-0415-2025",
     "D-0416-2025"
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    "products": [
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     "TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-",
     "TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0125-0"
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    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296792%22&limit=100",
    "classification": "Class II",
    "product_count": 5,
    "source": "openFDA drug enforcement API"
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  ],
  "timeline": [
   {
    "type": "regulatory_meeting",
    "date": "2026-03-03",
    "match": "table",
    "text": "Regulatory Meeting Held 3/3/2026",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "inspection",
    "date": "2025-07-16",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: 483",
    "url": "https://www.fda.gov/media/188200/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-07-16",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/188200/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-06-27",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Golden, CO); may be another site of the same company",
    "text": "483 Issued 06/27/2025 (PDF - 2 MB)",
    "url": "https://www.fda.gov/media/188193/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "BSO LLC (dba Belmar Select Outsourcing), Golden, CO - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "96792",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "BSO LLC",
    "firm_city": "Lakewood",
    "firm_state": "CO",
    "date": "2025-04-28",
    "report_date": "2025-05-14",
    "classification_date": "2025-05-06",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Particulate Matter: Glass particles were found in pellet vials."
    ],
    "recall_numbers": [
     "D-0412-2025",
     "D-0413-2025",
     "D-0414-2025",
     "D-0415-2025",
     "D-0416-2025"
    ],
    "products": [
     "TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0101-0",
     "TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0121-01",
     "TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0122-0",
     "TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-",
     "TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0125-0"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296792%22&limit=100",
    "classification": "Class II",
    "product_count": 5,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2024-07-03",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 07/03/2024 (PDF - 1 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/182398/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2021-09-15",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 09/15/2021",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO - 503B Facility"
   },
   {
    "type": "483",
    "date": "2021-03-11",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 03/11/2021 (PDF - 1 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/149780/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2020-06-22",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 6/22/2020 (PFD - 60 KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/140379/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO - 503B Facility"
   },
   {
    "type": "483",
    "date": "2019-09-20",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 09/20/2019 (PDF - 265 KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/132339/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO - 503B Facility"
   },
   {
    "type": "untitled_letter",
    "date": "2019-01-10",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Untitled Letter Issued 01/10/2019 (PDF - 698 KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/139424/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO - 503B Facility"
   }
  ],
  "counts": {
   "form483": 4,
   "warning_letters": 0,
   "recalls": 1,
   "uncertain_items": 1
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Colorado DORA License Lookup (State Board of Pharmacy)",
   "url": "https://apps2.colorado.gov/dora/licensing/Lookup/LicenseLookup.aspx",
   "kind": "license lookup"
  },
  "state_name": "Colorado"
 },
 {
  "listed_as": "Central Admixture Pharmacy Services, Inc., Allentown, PA",
  "name": "Central Admixture Pharmacy Services, Inc.",
  "city": "Allentown",
  "state": "PA",
  "phone": "1-551-204-4178",
  "initial_registration": "2/28/2014",
  "initial_registration_date": "2014-02-28",
  "recent_registration": "11/21/2025",
  "recent_registration_date": "2025-11-21",
  "last_inspection": "9/5/2025",
  "last_inspection_date": "2025-09-05",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/189925/download?attachment"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Regulatory Meeting Held 5/5/2026",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "central-admixture-pharmacy-services-inc-allentown-pa",
  "aliases": [
   "Central Admixture Pharmacy Services, Inc."
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Central Admixture Pharmacy Services, Inc. (CAPS), Allentown, PA - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   },
   {
    "heading": "Central Admixture Pharmacy Services, Inc. (CAPS), Cranberry Township, PA - 503A Facility",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Cranberry Township, PA); may be another site of the same company"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "96307",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Central Admixture Pharmacy Services, Inc.",
    "firm_city": "Allentown",
    "firm_state": "PA",
    "date": "2025-02-20",
    "report_date": "2025-03-19",
    "classification_date": "2025-03-11",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Particulate Matter"
    ],
    "recall_numbers": [
     "D-0272-2025"
    ],
    "products": [
     "PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296307%22&limit=100",
    "classification": "Class I",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "92253",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Central Admixture Pharmacy Services, Inc.",
    "firm_city": "Allentown",
    "firm_state": "PA",
    "date": "2023-04-28",
    "report_date": "2023-05-31",
    "classification_date": "2023-05-19",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile."
    ],
    "recall_numbers": [
     "D-0648-2023",
     "D-0649-2023",
     "D-0650-2023",
     "D-0651-2023",
     "D-0652-2023",
     "D-0653-2023",
     "D-0654-2023",
     "D-0655-2023",
     "D-0656-2023",
     "D-0657-2023",
     "D-0658-2023",
     "D-0659-2023",
     "D-0660-2023",
     "D-0661-2023",
     "D-0662-2023",
     "D-0663-2023",
     "D-0664-2023",
     "D-0665-2023",
     "D-0666-2023",
     "D-0667-2023",
     "D-0668-2023",
     "D-0669-2023",
     "D-0670-2023",
     "D-0671-2023",
     "D-0672-2023",
     "D-0673-2023",
     "D-0674-2023",
     "D-0675-2023",
     "D-0676-2023",
     "D-0677-2023",
     "D-0678-2023",
     "D-0679-2023",
     "D-0680-2023",
     "D-0681-2023",
     "D-0682-2023",
     "D-0683-2023",
     "D-0684-2023",
     "D-0685-2023",
     "D-0686-2023",
     "D-0687-2023",
     "D-0688-2023",
     "D-0689-2023",
     "D-0690-2023",
     "D-0691-2023",
     "D-0692-2023",
     "D-0693-2023",
     "D-0694-2023",
     "D-0695-2023",
     "D-0696-2023",
     "D-0697-2023",
     "D-0698-2023",
     "D-0699-2023",
     "D-0700-2023",
     "D-0701-2023",
     "D-0702-2023",
     "D-0703-2023",
     "D-0704-2023",
     "D-0705-2023",
     "D-0706-2023",
     "D-0707-2023",
     "D-0708-2023",
     "D-0709-2023",
     "D-0710-2023",
     "D-0711-2023",
     "D-0712-2023",
     "D-0713-2023",
     "D-0714-2023",
     "D-0715-2023",
     "D-0716-2023",
     "D-0717-2023",
     "D-0718-2023",
     "D-0719-2023",
     "D-0720-2023",
     "D-0721-2023",
     "D-0722-2023",
     "D-0723-2023",
     "D-0724-2023",
     "D-0725-2023",
     "D-0726-2023",
     "D-0727-2023",
     "D-0728-2023",
     "D-0729-2023",
     "D-0730-2023",
     "D-0731-2023",
     "D-0732-2023",
     "D-0733-2023",
     "D-0734-2023",
     "D-0735-2023",
     "D-0736-2023",
     "D-0737-2023",
     "D-0738-2023",
     "D-0739-2023",
     "D-0740-2023",
     "D-0741-2023",
     "D-0742-2023",
     "D-0743-2023",
     "D-0744-2023",
     "D-0745-2023",
     "D-0746-2023",
     "D-0747-2023",
     "D-0748-2023",
     "D-0749-2023",
     "D-0750-2023",
     "D-0751-2023",
     "D-0752-2023",
     "D-0753-2023",
     "D-0754-2023",
     "D-0755-2023"
    ],
    "products": [
     "vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA  18106, NDC 71285-9000-1.",
     "Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine, low potassium, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA  18106, NDC 71285-0112-1.",
     "Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA  18106, NDC 71285-0406-1.",
     "Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA  18106, NDC 71285-0011-1.",
     "MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA  18106, NDC 71285-8029-1, code 7128580291."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2292253%22&limit=100",
    "classification": "Class II",
    "product_count": 108,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "70148",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Central Admixture Pharmacy Services, Inc.",
    "firm_city": "Allentown",
    "firm_state": "PA",
    "date": "2014-12-17",
    "report_date": "2015-04-15",
    "classification_date": "2015-04-08",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Non-Sterility: Out of specification results for the sterility test for microbial contamination."
    ],
    "recall_numbers": [
     "D-437-2015",
     "D-438-2015",
     "D-439-2015",
     "D-440-2015",
     "D-441-2015",
     "D-442-2015",
     "D-443-2015",
     "D-444-2015",
     "D-445-2015",
     "D-446-2015",
     "D-447-2015",
     "D-448-2015",
     "D-449-2015",
     "D-450-2015",
     "D-451-2015",
     "D-452-2015",
     "D-453-2015",
     "D-454-2015",
     "D-455-2015",
     "D-456-2015",
     "D-457-2015",
     "D-458-2015",
     "D-459-2015",
     "D-460-2015",
     "D-461-2015",
     "D-462-2015",
     "D-463-2015",
     "D-464-2015",
     "D-465-2015",
     "D-466-2015",
     "D-467-2015",
     "D-468-2015",
     "D-469-2015",
     "D-470-2015"
    ],
    "products": [
     "Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46mEq/mL, 600 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrug",
     "Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acids, Neonate 3g, Dextrose 5%, 150 ml, Additives: heparin PF 75 units, Calcium Gluconate 300mg, compound vol: 150 ml,  sterile injectable, Rx only, compounded drug, I",
     "Rose Medical Center (CO) Neonate D5 Bridge, Trophamine 3% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is",
     "Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag with Calcium,  Trophamine 5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46 mEq/mL, 750mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag p",
     "Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 10%, Additives: heparin PF 1 unit(s)/ml, Calcium Gluconate 2.3mEq/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag "
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2270148%22&limit=100",
    "classification": "Class I",
    "product_count": 34,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "regulatory_meeting",
    "date": "2026-05-05",
    "match": "table",
    "text": "Regulatory Meeting Held 5/5/2026",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "inspection",
    "date": "2025-09-05",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/189925/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-09-05",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/189925/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "recall",
    "event_id": "96307",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Central Admixture Pharmacy Services, Inc.",
    "firm_city": "Allentown",
    "firm_state": "PA",
    "date": "2025-02-20",
    "report_date": "2025-03-19",
    "classification_date": "2025-03-11",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Particulate Matter"
    ],
    "recall_numbers": [
     "D-0272-2025"
    ],
    "products": [
     "PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296307%22&limit=100",
    "classification": "Class I",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "warning_letter",
    "date": "2024-03-29",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter Issued 03/29/2024",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/central-admixture-pharmacy-services-inc-674736-03292024",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Central Admixture Pharmacy Services, Inc. (CAPS), Allentown, PA - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "92253",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Central Admixture Pharmacy Services, Inc.",
    "firm_city": "Allentown",
    "firm_state": "PA",
    "date": "2023-04-28",
    "report_date": "2023-05-31",
    "classification_date": "2023-05-19",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile."
    ],
    "recall_numbers": [
     "D-0648-2023",
     "D-0649-2023",
     "D-0650-2023",
     "D-0651-2023",
     "D-0652-2023",
     "D-0653-2023",
     "D-0654-2023",
     "D-0655-2023",
     "D-0656-2023",
     "D-0657-2023",
     "D-0658-2023",
     "D-0659-2023",
     "D-0660-2023",
     "D-0661-2023",
     "D-0662-2023",
     "D-0663-2023",
     "D-0664-2023",
     "D-0665-2023",
     "D-0666-2023",
     "D-0667-2023",
     "D-0668-2023",
     "D-0669-2023",
     "D-0670-2023",
     "D-0671-2023",
     "D-0672-2023",
     "D-0673-2023",
     "D-0674-2023",
     "D-0675-2023",
     "D-0676-2023",
     "D-0677-2023",
     "D-0678-2023",
     "D-0679-2023",
     "D-0680-2023",
     "D-0681-2023",
     "D-0682-2023",
     "D-0683-2023",
     "D-0684-2023",
     "D-0685-2023",
     "D-0686-2023",
     "D-0687-2023",
     "D-0688-2023",
     "D-0689-2023",
     "D-0690-2023",
     "D-0691-2023",
     "D-0692-2023",
     "D-0693-2023",
     "D-0694-2023",
     "D-0695-2023",
     "D-0696-2023",
     "D-0697-2023",
     "D-0698-2023",
     "D-0699-2023",
     "D-0700-2023",
     "D-0701-2023",
     "D-0702-2023",
     "D-0703-2023",
     "D-0704-2023",
     "D-0705-2023",
     "D-0706-2023",
     "D-0707-2023",
     "D-0708-2023",
     "D-0709-2023",
     "D-0710-2023",
     "D-0711-2023",
     "D-0712-2023",
     "D-0713-2023",
     "D-0714-2023",
     "D-0715-2023",
     "D-0716-2023",
     "D-0717-2023",
     "D-0718-2023",
     "D-0719-2023",
     "D-0720-2023",
     "D-0721-2023",
     "D-0722-2023",
     "D-0723-2023",
     "D-0724-2023",
     "D-0725-2023",
     "D-0726-2023",
     "D-0727-2023",
     "D-0728-2023",
     "D-0729-2023",
     "D-0730-2023",
     "D-0731-2023",
     "D-0732-2023",
     "D-0733-2023",
     "D-0734-2023",
     "D-0735-2023",
     "D-0736-2023",
     "D-0737-2023",
     "D-0738-2023",
     "D-0739-2023",
     "D-0740-2023",
     "D-0741-2023",
     "D-0742-2023",
     "D-0743-2023",
     "D-0744-2023",
     "D-0745-2023",
     "D-0746-2023",
     "D-0747-2023",
     "D-0748-2023",
     "D-0749-2023",
     "D-0750-2023",
     "D-0751-2023",
     "D-0752-2023",
     "D-0753-2023",
     "D-0754-2023",
     "D-0755-2023"
    ],
    "products": [
     "vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA  18106, NDC 71285-9000-1.",
     "Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine, low potassium, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA  18106, NDC 71285-0112-1.",
     "Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA  18106, NDC 71285-0406-1.",
     "Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA  18106, NDC 71285-0011-1.",
     "MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA  18106, NDC 71285-8029-1, code 7128580291."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2292253%22&limit=100",
    "classification": "Class II",
    "product_count": 108,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2023-03-30",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 03/30/2023 (PDF - 2 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/170878/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Central Admixture Pharmacy Services, Inc. (CAPS), Allentown, PA - 503B Facility"
   },
   {
    "type": "state_referral",
    "date": "2022-10-11",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Cranberry Township, PA); may be another site of the same company",
    "text": "State Referral Letter Issued 10/11/2022",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Central Admixture Pharmacy Services, Inc. (CAPS), Cranberry Township, PA - 503A Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2022-10-11",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Cranberry Township, PA); may be another site of the same company",
    "text": "FMD-145 Issued 10/11/2022",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Central Admixture Pharmacy Services, Inc. (CAPS), Cranberry Township, PA - 503A Facility"
   },
   {
    "type": "483",
    "date": "2022-05-04",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Cranberry Township, PA); may be another site of the same company",
    "text": "483 Issued 05/04/2022 (PDF - 6 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/159421/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Central Admixture Pharmacy Services, Inc. (CAPS), Cranberry Township, PA - 503A Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2020-06-17",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 06/17/2020 (PDF - 74KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/141701/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Central Admixture Pharmacy Services, Inc. (CAPS), Allentown, PA - 503B Facility"
   },
   {
    "type": "warning_letter_closeout",
    "date": "2020-06-17",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter Closeout Issued 06/17/2020",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Central Admixture Pharmacy Services, Inc. (CAPS), Allentown, PA - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "70148",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Central Admixture Pharmacy Services, Inc.",
    "firm_city": "Allentown",
    "firm_state": "PA",
    "date": "2014-12-17",
    "report_date": "2015-04-15",
    "classification_date": "2015-04-08",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Non-Sterility: Out of specification results for the sterility test for microbial contamination."
    ],
    "recall_numbers": [
     "D-437-2015",
     "D-438-2015",
     "D-439-2015",
     "D-440-2015",
     "D-441-2015",
     "D-442-2015",
     "D-443-2015",
     "D-444-2015",
     "D-445-2015",
     "D-446-2015",
     "D-447-2015",
     "D-448-2015",
     "D-449-2015",
     "D-450-2015",
     "D-451-2015",
     "D-452-2015",
     "D-453-2015",
     "D-454-2015",
     "D-455-2015",
     "D-456-2015",
     "D-457-2015",
     "D-458-2015",
     "D-459-2015",
     "D-460-2015",
     "D-461-2015",
     "D-462-2015",
     "D-463-2015",
     "D-464-2015",
     "D-465-2015",
     "D-466-2015",
     "D-467-2015",
     "D-468-2015",
     "D-469-2015",
     "D-470-2015"
    ],
    "products": [
     "Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46mEq/mL, 600 mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrug",
     "Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acids, Neonate 3g, Dextrose 5%, 150 ml, Additives: heparin PF 75 units, Calcium Gluconate 300mg, compound vol: 150 ml,  sterile injectable, Rx only, compounded drug, I",
     "Rose Medical Center (CO) Neonate D5 Bridge, Trophamine 3% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is",
     "Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag with Calcium,  Trophamine 5 gm, Dextrose 10%, Additives: Calcium Gluconate 0.46 mEq/mL, 750mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag p",
     "Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , Dextrose 10%, Additives: heparin PF 1 unit(s)/ml, Calcium Gluconate 2.3mEq/dL, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag "
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2270148%22&limit=100",
    "classification": "Class I",
    "product_count": 34,
    "source": "openFDA drug enforcement API"
   }
  ],
  "counts": {
   "form483": 2,
   "warning_letters": 1,
   "recalls": 3,
   "uncertain_items": 3
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Pennsylvania Licensing System (PALS) Verification (State Board of Pharmacy)",
   "url": "https://www.pals.pa.gov/",
   "kind": "license lookup"
  },
  "state_name": "Pennsylvania"
 },
 {
  "listed_as": "Central Admixture Pharmacy Services, Phoenix, AZ",
  "name": "Central Admixture Pharmacy Services",
  "city": "Phoenix",
  "state": "AZ",
  "phone": "1-551-204-4178",
  "initial_registration": "3/29/2018",
  "initial_registration_date": "2018-03-29",
  "recent_registration": "11/21/2025",
  "recent_registration_date": "2025-11-21",
  "last_inspection": "9/5/2025",
  "last_inspection_date": "2025-09-05",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/189889/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Regulatory Meeting Held 5/5/2026",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "central-admixture-pharmacy-services-phoenix-az",
  "aliases": [
   "Central Admixture Pharmacy Services"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Central Admixture Pharmacy Services, Inc., Phoenix, AZ - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "92898",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Central Admixture Pharmacy Services, Inc.",
    "firm_city": "Phoenix",
    "firm_state": "AZ",
    "date": "2023-08-17",
    "report_date": "2023-09-06",
    "classification_date": "2023-08-28",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility:Lack of validation data for sanitization cycles"
    ],
    "recall_numbers": [
     "D-1107-2023",
     "D-1108-2023",
     "D-1109-2023",
     "D-1110-2023",
     "D-1111-2023",
     "D-1112-2023",
     "D-1113-2023",
     "D-1114-2023",
     "D-1115-2023",
     "D-1116-2023",
     "D-1117-2023",
     "D-1118-2023",
     "D-1119-2023",
     "D-1120-2023",
     "D-1121-2023",
     "D-1122-2023",
     "D-1123-2023",
     "D-1124-2023",
     "D-1125-2023",
     "D-1126-2023",
     "D-1127-2023",
     "D-1128-2023",
     "D-1129-2023",
     "D-1130-2023",
     "D-1131-2023",
     "D-1132-2023",
     "D-1133-2023",
     "D-1134-2023",
     "D-1135-2023",
     "D-1136-2023",
     "D-1137-2023",
     "D-1138-2023"
    ],
    "products": [
     "EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.",
     "EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.",
     "Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0431-1",
     "heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1",
     "Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0406-1"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2292898%22&limit=100",
    "classification": "Class II",
    "product_count": 32,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "92707",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Central Admixture Pharmacy Services, Inc.",
    "firm_city": "Phoenix",
    "firm_state": "AZ",
    "date": "2023-07-14",
    "report_date": "2023-08-09",
    "classification_date": "2023-08-01",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of assurance of sterility. Validation data for decontamination cycles is lacking."
    ],
    "recall_numbers": [
     "D-0947-2023",
     "D-0948-2023",
     "D-0949-2023",
     "D-0950-2023",
     "D-0951-2023",
     "D-0952-2023",
     "D-0953-2023",
     "D-0954-2023",
     "D-0955-2023",
     "D-0956-2023",
     "D-0957-2023",
     "D-0958-2023",
     "D-0959-2023",
     "D-0960-2023",
     "D-0961-2023",
     "D-0962-2023",
     "D-0963-2023",
     "D-0964-2023",
     "D-0965-2023",
     "D-0966-2023",
     "D-0967-2023",
     "D-0968-2023",
     "D-0969-2023",
     "D-0970-2023",
     "D-0971-2023",
     "D-0972-2023",
     "D-0973-2023",
     "D-0974-2023",
     "D-0975-2023",
     "D-0976-2023",
     "D-0977-2023",
     "D-0978-2023",
     "D-0979-2023",
     "D-0980-2023",
     "D-0981-2023",
     "D-0982-2023",
     "D-0983-2023",
     "D-0984-2023",
     "D-0985-2023",
     "D-0986-2023",
     "D-0987-2023",
     "D-0988-2023",
     "D-0989-2023",
     "D-0990-2023",
     "D-0991-2023",
     "D-0992-2023",
     "D-0993-2023",
     "D-0994-2023",
     "D-0995-2023",
     "D-0996-2023",
     "D-0997-2023",
     "D-0998-2023",
     "D-0999-2023",
     "D-1000-2023",
     "D-1001-2023",
     "D-1002-2023",
     "D-1003-2023",
     "D-1004-2023",
     "D-1005-2023",
     "D-1006-2023",
     "D-1007-2023",
     "D-1008-2023",
     "D-1009-2023",
     "D-1010-2023",
     "D-1011-2023",
     "D-1012-2023",
     "D-1013-2023",
     "D-1014-2023",
     "D-1015-2023",
     "D-1016-2023",
     "D-1017-2023",
     "D-1018-2023",
     "D-1019-2023",
     "D-1020-2023",
     "D-1021-2023",
     "D-1022-2023",
     "D-1023-2023",
     "D-1024-2023",
     "D-1025-2023",
     "D-1026-2023",
     "D-1027-2023",
     "D-1028-2023",
     "D-1029-2023",
     "D-1030-2023",
     "D-1031-2023",
     "D-1032-2023",
     "D-1033-2023",
     "D-1034-2023",
     "D-1035-2023",
     "D-1036-2023",
     "D-1037-2023",
     "D-1038-2023",
     "D-1039-2023",
     "D-1040-2023",
     "D-1041-2023"
    ],
    "products": [
     "Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM, total volume = 250mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0413-1",
     "vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6075-1",
     "CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High Potassium, IV Bag, total volume = 500 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0102-1",
     "oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1",
     "Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0427"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2292707%22&limit=100",
    "classification": "Class II",
    "product_count": 95,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "regulatory_meeting",
    "date": "2026-05-05",
    "match": "table",
    "text": "Regulatory Meeting Held 5/5/2026",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "inspection",
    "date": "2025-09-05",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/189889/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-09-05",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/189889/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "warning_letter",
    "date": "2024-03-25",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter Issued 03/25/2024",
    "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/central-admixture-pharmacy-services-inc-675065-03252024",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Central Admixture Pharmacy Services, Inc., Phoenix, AZ - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "92898",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Central Admixture Pharmacy Services, Inc.",
    "firm_city": "Phoenix",
    "firm_state": "AZ",
    "date": "2023-08-17",
    "report_date": "2023-09-06",
    "classification_date": "2023-08-28",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility:Lack of validation data for sanitization cycles"
    ],
    "recall_numbers": [
     "D-1107-2023",
     "D-1108-2023",
     "D-1109-2023",
     "D-1110-2023",
     "D-1111-2023",
     "D-1112-2023",
     "D-1113-2023",
     "D-1114-2023",
     "D-1115-2023",
     "D-1116-2023",
     "D-1117-2023",
     "D-1118-2023",
     "D-1119-2023",
     "D-1120-2023",
     "D-1121-2023",
     "D-1122-2023",
     "D-1123-2023",
     "D-1124-2023",
     "D-1125-2023",
     "D-1126-2023",
     "D-1127-2023",
     "D-1128-2023",
     "D-1129-2023",
     "D-1130-2023",
     "D-1131-2023",
     "D-1132-2023",
     "D-1133-2023",
     "D-1134-2023",
     "D-1135-2023",
     "D-1136-2023",
     "D-1137-2023",
     "D-1138-2023"
    ],
    "products": [
     "EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.",
     "EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.",
     "Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0431-1",
     "heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1",
     "Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0406-1"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2292898%22&limit=100",
    "classification": "Class II",
    "product_count": 32,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2023-07-31",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 7/31/2023",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/173408/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Central Admixture Pharmacy Services, Inc., Phoenix, AZ - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "92707",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Central Admixture Pharmacy Services, Inc.",
    "firm_city": "Phoenix",
    "firm_state": "AZ",
    "date": "2023-07-14",
    "report_date": "2023-08-09",
    "classification_date": "2023-08-01",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of assurance of sterility. Validation data for decontamination cycles is lacking."
    ],
    "recall_numbers": [
     "D-0947-2023",
     "D-0948-2023",
     "D-0949-2023",
     "D-0950-2023",
     "D-0951-2023",
     "D-0952-2023",
     "D-0953-2023",
     "D-0954-2023",
     "D-0955-2023",
     "D-0956-2023",
     "D-0957-2023",
     "D-0958-2023",
     "D-0959-2023",
     "D-0960-2023",
     "D-0961-2023",
     "D-0962-2023",
     "D-0963-2023",
     "D-0964-2023",
     "D-0965-2023",
     "D-0966-2023",
     "D-0967-2023",
     "D-0968-2023",
     "D-0969-2023",
     "D-0970-2023",
     "D-0971-2023",
     "D-0972-2023",
     "D-0973-2023",
     "D-0974-2023",
     "D-0975-2023",
     "D-0976-2023",
     "D-0977-2023",
     "D-0978-2023",
     "D-0979-2023",
     "D-0980-2023",
     "D-0981-2023",
     "D-0982-2023",
     "D-0983-2023",
     "D-0984-2023",
     "D-0985-2023",
     "D-0986-2023",
     "D-0987-2023",
     "D-0988-2023",
     "D-0989-2023",
     "D-0990-2023",
     "D-0991-2023",
     "D-0992-2023",
     "D-0993-2023",
     "D-0994-2023",
     "D-0995-2023",
     "D-0996-2023",
     "D-0997-2023",
     "D-0998-2023",
     "D-0999-2023",
     "D-1000-2023",
     "D-1001-2023",
     "D-1002-2023",
     "D-1003-2023",
     "D-1004-2023",
     "D-1005-2023",
     "D-1006-2023",
     "D-1007-2023",
     "D-1008-2023",
     "D-1009-2023",
     "D-1010-2023",
     "D-1011-2023",
     "D-1012-2023",
     "D-1013-2023",
     "D-1014-2023",
     "D-1015-2023",
     "D-1016-2023",
     "D-1017-2023",
     "D-1018-2023",
     "D-1019-2023",
     "D-1020-2023",
     "D-1021-2023",
     "D-1022-2023",
     "D-1023-2023",
     "D-1024-2023",
     "D-1025-2023",
     "D-1026-2023",
     "D-1027-2023",
     "D-1028-2023",
     "D-1029-2023",
     "D-1030-2023",
     "D-1031-2023",
     "D-1032-2023",
     "D-1033-2023",
     "D-1034-2023",
     "D-1035-2023",
     "D-1036-2023",
     "D-1037-2023",
     "D-1038-2023",
     "D-1039-2023",
     "D-1040-2023",
     "D-1041-2023"
    ],
    "products": [
     "Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM, total volume = 250mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0413-1",
     "vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6075-1",
     "CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High Potassium, IV Bag, total volume = 500 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0102-1",
     "oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1",
     "Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0427"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2292707%22&limit=100",
    "classification": "Class II",
    "product_count": 95,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "fmd145_letter",
    "date": "2023-01-18",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 1/18/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Central Admixture Pharmacy Services, Inc., Phoenix, AZ - 503B Facility"
   },
   {
    "type": "warning_letter_response",
    "date": "2023-01-11",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter Response 01/11/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Central Admixture Pharmacy Services, Inc., Phoenix, AZ - 503B Facility"
   },
   {
    "type": "483",
    "date": "2022-02-25",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 02/25/2022 (PDF - 2 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/159221/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Central Admixture Pharmacy Services, Inc., Phoenix, AZ - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2020-06-03",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 06/03/2020 (PDF - 57 KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/139371/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Central Admixture Pharmacy Services, Inc., Phoenix, AZ - 503B Facility"
   }
  ],
  "counts": {
   "form483": 3,
   "warning_letters": 1,
   "recalls": 2,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Arizona State Board of Pharmacy",
   "url": "https://pharmacy.az.gov/",
   "kind": "board site"
  },
  "state_name": "Arizona"
 },
 {
  "listed_as": "Delta Pharma, Inc., Ripley, MS",
  "name": "Delta Pharma, Inc.",
  "city": "Ripley",
  "state": "MS",
  "phone": "662-512-5191",
  "initial_registration": "8/6/2014",
  "initial_registration_date": "2014-08-06",
  "recent_registration": "12/31/2025",
  "recent_registration_date": "2025-12-31",
  "last_inspection": "11/21/2025",
  "last_inspection_date": "2025-11-21",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/190199/download?attachment"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "delta-pharma-inc-ripley-ms",
  "aliases": [
   "Delta Pharma, Inc."
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Delta Pharma, Inc., Ripley, MS - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "inspection",
    "date": "2025-11-21",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/190199/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-11-21",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/190199/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "fmd145_letter",
    "date": "2025-07-29",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 07/29/2025",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Delta Pharma, Inc., Ripley, MS - 503B Facility"
   },
   {
    "type": "483",
    "date": "2024-04-12",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 04/12/2024 (PDF - 1 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/178599/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Delta Pharma, Inc., Ripley, MS - 503B Facility"
   },
   {
    "type": "483",
    "date": "2023-06-02",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 06/02/2023 (PDF - 229 KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/171282/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Delta Pharma, Inc., Ripley, MS - 503B Facility"
   },
   {
    "type": "483",
    "date": "2022-05-20",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 05/20/2022 (PDF - 2 MB)",
    "url": "https://www.fda.gov/media/160070/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Delta Pharma, Inc., Ripley, MS - 503B Facility"
   }
  ],
  "counts": {
   "form483": 4,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Mississippi Board of Pharmacy",
   "url": "https://www.mbp.ms.gov/",
   "kind": "board site"
  },
  "state_name": "Mississippi"
 },
 {
  "listed_as": "Denver Solutions, LLC, dba Leiters Health, Englewood, CO",
  "name": "Denver Solutions, LLC, dba Leiters Health",
  "city": "Englewood",
  "state": "CO",
  "phone": "720-697-5140 Ext 4004",
  "initial_registration": "3/24/2017",
  "initial_registration_date": "2017-03-24",
  "recent_registration": "11/28/2025",
  "recent_registration_date": "2025-11-28",
  "last_inspection": "12/11/2025",
  "last_inspection_date": "2025-12-11",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/190719/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Untitled Letter Issued 6/8/2026",
  "action_links": [
   {
    "text": "Untitled Letter Issued 6/8/2026",
    "url": "https://www.fda.gov/media/193646/download"
   }
  ],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "denver-solutions-llc-dba-leiters-health-englewood-co",
  "aliases": [
   "Denver Solutions, LLC",
   "Leiters Health"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Denver Solutions, LLC (dba Leiter's Health), Englewood, CO - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "96607",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Denver Solutions, LLC DBA Leiters Health",
    "firm_city": "Englewood",
    "firm_state": "CO",
    "date": "2025-03-31",
    "report_date": "2025-04-30",
    "classification_date": "2025-04-18",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility: Leaking/damaged syringes."
    ],
    "recall_numbers": [
     "D-0370-2025",
     "D-0371-2025",
     "D-0372-2025",
     "D-0373-2025",
     "D-0374-2025"
    ],
    "products": [
     "Rocuronium Bromide 50 mg per 5mL (10mg per mL),  5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11",
     "dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11.",
     "Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11",
     "Ketamine HCl 50mg per 5mL (10 mg per mL),  5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11",
     "PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296607%22&limit=100",
    "classification": "Class II",
    "product_count": 5,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "94071",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Denver Solutions, LLC DBA Leiters Health",
    "firm_city": "Englewood",
    "firm_state": "CO",
    "date": "2024-02-20",
    "report_date": "2024-03-06",
    "classification_date": "2024-02-29",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination."
    ],
    "recall_numbers": [
     "D-0361-2024",
     "D-0362-2024",
     "D-0363-2024"
    ],
    "products": [
     "Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42",
     "Lidocaine HCL 1% (10mg/mL),  PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42",
     "Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2294071%22&limit=100",
    "classification": "Class II",
    "product_count": 3,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "93710",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Denver Solutions, LLC DBA Leiters Health",
    "firm_city": "Englewood",
    "firm_state": "CO",
    "date": "2023-12-28",
    "report_date": "2024-02-07",
    "classification_date": "2024-01-29",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags."
    ],
    "recall_numbers": [
     "D-0277-2024",
     "D-0278-2024",
     "D-0279-2024",
     "D-0280-2024",
     "D-0281-2024",
     "D-0282-2024"
    ],
    "products": [
     "VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.",
     "FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.",
     "VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.",
     "FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.",
     "PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293710%22&limit=100",
    "classification": "Class I",
    "product_count": 6,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "93178",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Denver Solutions, LLC DBA Leiters Health",
    "firm_city": "Englewood",
    "firm_state": "CO",
    "date": "2023-10-04",
    "report_date": "2023-11-01",
    "classification_date": "2023-10-26",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Not Elsewhere Classified"
    ],
    "recall_numbers": [
     "D-0070-2024",
     "D-0071-2024",
     "D-0072-2024"
    ],
    "products": [
     "VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68.",
     "VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68.",
     "Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293178%22&limit=100",
    "classification": "Class III",
    "product_count": 3,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "91762",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Denver Solutions, LLC DBA Leiters Health",
    "firm_city": "Englewood",
    "firm_state": "CO",
    "date": "2023-02-21",
    "report_date": "2023-03-15",
    "classification_date": "2023-03-07",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "CGMP DEVIATIONS"
    ],
    "recall_numbers": [
     "D-0442-2023",
     "D-0443-2023",
     "D-0444-2023",
     "D-0445-2023"
    ],
    "products": [
     "Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag,  Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82",
     "Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11",
     "Phenylephrine HCl  1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15",
     "Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291762%22&limit=100",
    "classification": "Class II",
    "product_count": 4,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "89136",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Denver Solutions, LLC DBA Leiters Health",
    "firm_city": "Englewood",
    "firm_state": "CO",
    "date": "2021-11-29",
    "report_date": "2021-12-29",
    "classification_date": "2021-12-17",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL"
    ],
    "recall_numbers": [
     "D-0288-2022"
    ],
    "products": [
     "Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2289136%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "untitled_letter",
    "date": "2026-06-08",
    "match": "table",
    "text": "Untitled Letter Issued 6/8/2026",
    "url": "https://www.fda.gov/media/193646/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "inspection",
    "date": "2025-12-11",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/190719/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-12-11",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/190719/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "recall",
    "event_id": "96607",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Denver Solutions, LLC DBA Leiters Health",
    "firm_city": "Englewood",
    "firm_state": "CO",
    "date": "2025-03-31",
    "report_date": "2025-04-30",
    "classification_date": "2025-04-18",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility: Leaking/damaged syringes."
    ],
    "recall_numbers": [
     "D-0370-2025",
     "D-0371-2025",
     "D-0372-2025",
     "D-0373-2025",
     "D-0374-2025"
    ],
    "products": [
     "Rocuronium Bromide 50 mg per 5mL (10mg per mL),  5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11",
     "dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11.",
     "Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11",
     "Ketamine HCl 50mg per 5mL (10 mg per mL),  5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11",
     "PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-001-11,"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296607%22&limit=100",
    "classification": "Class II",
    "product_count": 5,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "fmd145_letter",
    "date": "2024-11-20",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 11/20/2024",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Denver Solutions, LLC (dba Leiter's Health), Englewood, CO - 503B Facility"
   },
   {
    "type": "483",
    "date": "2024-04-05",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 04/05/2024 (PDF - 2 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/180028/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Denver Solutions, LLC (dba Leiter's Health), Englewood, CO - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "94071",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Denver Solutions, LLC DBA Leiters Health",
    "firm_city": "Englewood",
    "firm_state": "CO",
    "date": "2024-02-20",
    "report_date": "2024-03-06",
    "classification_date": "2024-02-29",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination."
    ],
    "recall_numbers": [
     "D-0361-2024",
     "D-0362-2024",
     "D-0363-2024"
    ],
    "products": [
     "Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42",
     "Lidocaine HCL 1% (10mg/mL),  PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42",
     "Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2294071%22&limit=100",
    "classification": "Class II",
    "product_count": 3,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "93710",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Denver Solutions, LLC DBA Leiters Health",
    "firm_city": "Englewood",
    "firm_state": "CO",
    "date": "2023-12-28",
    "report_date": "2024-02-07",
    "classification_date": "2024-01-29",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags."
    ],
    "recall_numbers": [
     "D-0277-2024",
     "D-0278-2024",
     "D-0279-2024",
     "D-0280-2024",
     "D-0281-2024",
     "D-0282-2024"
    ],
    "products": [
     "VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.",
     "FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.",
     "VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.",
     "FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.",
     "PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293710%22&limit=100",
    "classification": "Class I",
    "product_count": 6,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "93178",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Denver Solutions, LLC DBA Leiters Health",
    "firm_city": "Englewood",
    "firm_state": "CO",
    "date": "2023-10-04",
    "report_date": "2023-11-01",
    "classification_date": "2023-10-26",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Not Elsewhere Classified"
    ],
    "recall_numbers": [
     "D-0070-2024",
     "D-0071-2024",
     "D-0072-2024"
    ],
    "products": [
     "VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68.",
     "VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68.",
     "Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293178%22&limit=100",
    "classification": "Class III",
    "product_count": 3,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "91762",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Denver Solutions, LLC DBA Leiters Health",
    "firm_city": "Englewood",
    "firm_state": "CO",
    "date": "2023-02-21",
    "report_date": "2023-03-15",
    "classification_date": "2023-03-07",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "CGMP DEVIATIONS"
    ],
    "recall_numbers": [
     "D-0442-2023",
     "D-0443-2023",
     "D-0444-2023",
     "D-0445-2023"
    ],
    "products": [
     "Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag,  Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82",
     "Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11",
     "Phenylephrine HCl  1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15",
     "Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291762%22&limit=100",
    "classification": "Class II",
    "product_count": 4,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "fmd145_letter",
    "date": "2022-03-29",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 03/29/2022",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Denver Solutions, LLC (dba Leiter's Health), Englewood, CO - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "89136",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Denver Solutions, LLC DBA Leiters Health",
    "firm_city": "Englewood",
    "firm_state": "CO",
    "date": "2021-11-29",
    "report_date": "2021-12-29",
    "classification_date": "2021-12-17",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL"
    ],
    "recall_numbers": [
     "D-0288-2022"
    ],
    "products": [
     "Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2289136%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2021-10-07",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 10/07/2021 (PDF - 9 MB)",
    "url": "https://www.fda.gov/media/156279/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Denver Solutions, LLC (dba Leiter's Health), Englewood, CO - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2021-05-26",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter 05/26/2021",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Denver Solutions, LLC (dba Leiter's Health), Englewood, CO - 503B Facility"
   },
   {
    "type": "483",
    "date": "2019-07-18",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 07/18/2019 (PDF - 606 KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/131040/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Denver Solutions, LLC (dba Leiter's Health), Englewood, CO - 503B Facility"
   }
  ],
  "counts": {
   "form483": 4,
   "warning_letters": 0,
   "recalls": 6,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Colorado DORA License Lookup (State Board of Pharmacy)",
   "url": "https://apps2.colorado.gov/dora/licensing/Lookup/LicenseLookup.aspx",
   "kind": "license lookup"
  },
  "state_name": "Colorado"
 },
 {
  "listed_as": "Denver Solutions, LLC, dba Leiters Health, Buena, NJ",
  "name": "Denver Solutions, LLC, dba Leiters Health",
  "city": "Buena",
  "state": "NJ",
  "phone": "720-697-5140 Ext 4004",
  "initial_registration": "7/1/2022",
  "initial_registration_date": "2022-07-01",
  "recent_registration": "11/26/2025",
  "recent_registration_date": "2025-11-26",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "denver-solutions-llc-dba-leiters-health-buena-nj",
  "aliases": [
   "Denver Solutions, LLC",
   "Leiters Health"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "New Jersey Board of Pharmacy License Verification",
   "url": "https://newjersey.mylicense.com/verification/",
   "kind": "license lookup"
  },
  "state_name": "New Jersey"
 },
 {
  "listed_as": "Eagle Pharma, Birmingham, AL",
  "name": "Eagle Pharma",
  "city": "Birmingham",
  "state": "AL",
  "phone": "205-682-7999",
  "initial_registration": "6/16/2015",
  "initial_registration_date": "2015-06-16",
  "recent_registration": "12/16/2025",
  "recent_registration_date": "2025-12-16",
  "last_inspection": "9/29/2026",
  "last_inspection_date": "2026-09-29",
  "form483_issued": "Yes",
  "form483_links": [],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "eagle-pharma-birmingham-al",
  "aliases": [
   "Eagle Pharma"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-09-29",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-09-29",
    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table (no document link published there)",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   }
  ],
  "counts": {
   "form483": 1,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Alabama State Board of Pharmacy",
   "url": "https://www.albop.com/",
   "kind": "board site"
  },
  "state_name": "Alabama"
 },
 {
  "listed_as": "Empower Clinic Services New Jersey, East Windsor, NJ",
  "name": "Empower Clinic Services New Jersey",
  "city": "East Windsor",
  "state": "NJ",
  "phone": "334-315-9888",
  "initial_registration": "6/10/2024",
  "initial_registration_date": "2024-06-10",
  "recent_registration": "11/24/2025",
  "recent_registration_date": "2025-11-24",
  "last_inspection": "Not yet Inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "empower-clinic-services-new-jersey-east-windsor-nj",
  "aliases": [
   "Empower Clinic Services New Jersey"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "New Jersey Board of Pharmacy License Verification",
   "url": "https://newjersey.mylicense.com/verification/",
   "kind": "license lookup"
  },
  "state_name": "New Jersey"
 },
 {
  "listed_as": "Empower Pharma, Houston, TX",
  "name": "Empower Pharma",
  "city": "Houston",
  "state": "TX",
  "phone": "877-562-8577",
  "initial_registration": "7/16/2016",
  "initial_registration_date": "2016-07-16",
  "recent_registration": "11/24/2025",
  "recent_registration_date": "2025-11-24",
  "last_inspection": "11/14/2025",
  "last_inspection_date": "2025-11-14",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/190736/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "empower-pharma-houston-tx",
  "aliases": [
   "Empower Pharma"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX - 503B Facility",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "inspection",
    "date": "2025-11-14",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/190736/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-11-14",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/190736/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "warning_letter",
    "date": "2025-04-02",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state",
    "text": "Warning Letter Issued 04/02/2025",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharma-700962-04022025",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX - 503B Facility"
   },
   {
    "type": "483",
    "date": "2024-08-28",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state",
    "text": "483 Issued 08/28/2024 (PDF - 2.25MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/182593/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX - 503B Facility"
   },
   {
    "type": "regulatory_meeting",
    "date": "2023-05-04",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state",
    "text": "Regulatory Meeting Held 05/04/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX - 503B Facility"
   },
   {
    "type": "483",
    "date": "2022-08-05",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state",
    "text": "483 Issued 08/05/2022 (PDF - 20.4MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/162155/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX - 503B Facility"
   },
   {
    "type": "warning_letter",
    "date": "2021-10-15",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state",
    "text": "Warning Letter (10/15/2021)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-613792-10152021",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX - 503B Facility"
   },
   {
    "type": "483",
    "date": "2020-03-06",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state",
    "text": "483 Issued 03/06/2020 (PDF - 1.02MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/137544/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX - 503B Facility"
   },
   {
    "type": "untitled_letter",
    "date": "2019-07-22",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state",
    "text": "Untitled Letter Issued 07/22/2019 (PDF - 106KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/130590/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2019-04-02",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state",
    "text": "FMD-145 Letter Issued 04/02/2019 (PDF - 51KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/138390/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Empower Clinic Services, LLC, (dba Empower Pharmacy), Houston, TX - 503B Facility"
   }
  ],
  "counts": {
   "form483": 1,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 8
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Texas State Board of Pharmacy License Verification",
   "url": "https://www.pharmacy.texas.gov/dbsearch/phy_search.asp",
   "kind": "license lookup"
  },
  "state_name": "Texas"
 },
 {
  "listed_as": "F.H. Investments, Inc., Birmingham, AL",
  "name": "F.H. Investments, Inc.",
  "city": "Birmingham",
  "state": "AL",
  "phone": "1-205-995-0505",
  "initial_registration": "5/13/2025",
  "initial_registration_date": "2025-05-13",
  "recent_registration": "12/2/2025",
  "recent_registration_date": "2025-12-02",
  "last_inspection": "12/19/2025",
  "last_inspection_date": "2025-12-19",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/191003/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "f-h-investments-inc-birmingham-al",
  "aliases": [
   "F.H. Investments, Inc."
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "FH Investments Inc., (dba Asteria Health), Birmingham, AL - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "inspection",
    "date": "2025-12-19",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/191003/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-12-19",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/191003/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "fmd145_letter",
    "date": "2025-05-08",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 05/08/2025",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "FH Investments Inc., (dba Asteria Health), Birmingham, AL - 503B Facility"
   },
   {
    "type": "483",
    "date": "2024-11-08",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 11/08/2024 (PDF - 1.91MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/185398/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "FH Investments Inc., (dba Asteria Health), Birmingham, AL - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2021-09-10",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 09/10/2021",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "FH Investments Inc., (dba Asteria Health), Birmingham, AL - 503B Facility"
   }
  ],
  "counts": {
   "form483": 2,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Alabama State Board of Pharmacy",
   "url": "https://www.albop.com/",
   "kind": "board site"
  },
  "state_name": "Alabama"
 },
 {
  "listed_as": "Farmakeio Outsourcing LLC, Southlake, TX",
  "name": "Farmakeio Outsourcing LLC",
  "city": "Southlake",
  "state": "TX",
  "phone": "817-203-8216",
  "initial_registration": "12/12/2018",
  "initial_registration_date": "2018-12-12",
  "recent_registration": "12/12/2025",
  "recent_registration_date": "2025-12-12",
  "last_inspection": "9/5/2025",
  "last_inspection_date": "2025-09-05",
  "form483_issued": "Yes",
  "form483_links": [],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "farmakeio-outsourcing-llc-southlake-tx",
  "aliases": [
   "Farmakeio Outsourcing LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Farmakeio Outsourcing LLC, Southlake, TX - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "97799",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "FARMAKEIO OUTSOURCING LLC",
    "firm_city": "Southlake",
    "firm_state": "TX",
    "date": "2025-10-14",
    "report_date": "2025-11-05",
    "classification_date": "2025-10-29",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "CGMP Deviations: Potential presence of metal particulate matter"
    ],
    "recall_numbers": [
     "D-0123-2026",
     "D-0124-2026",
     "D-0125-2026",
     "D-0126-2026",
     "D-0127-2026",
     "D-0128-2026",
     "D-0129-2026",
     "D-0130-2026",
     "D-0131-2026",
     "D-0132-2026",
     "D-0133-2026",
     "D-0134-2026",
     "D-0135-2026",
     "D-0136-2026",
     "D-0137-2026"
    ],
    "products": [
     "Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01",
     "Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0387-01",
     "Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01",
     "Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01",
     "Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297799%22&limit=100",
    "classification": "Class II",
    "product_count": 15,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "recall",
    "event_id": "97799",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "FARMAKEIO OUTSOURCING LLC",
    "firm_city": "Southlake",
    "firm_state": "TX",
    "date": "2025-10-14",
    "report_date": "2025-11-05",
    "classification_date": "2025-10-29",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "CGMP Deviations: Potential presence of metal particulate matter"
    ],
    "recall_numbers": [
     "D-0123-2026",
     "D-0124-2026",
     "D-0125-2026",
     "D-0126-2026",
     "D-0127-2026",
     "D-0128-2026",
     "D-0129-2026",
     "D-0130-2026",
     "D-0131-2026",
     "D-0132-2026",
     "D-0133-2026",
     "D-0134-2026",
     "D-0135-2026",
     "D-0136-2026",
     "D-0137-2026"
    ],
    "products": [
     "Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01",
     "Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0387-01",
     "Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01",
     "Testosterone / Triamcinolone Acetonide Pellet (100MG/20MCG), 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0367-01",
     "Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297799%22&limit=100",
    "classification": "Class II",
    "product_count": 15,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "inspection",
    "date": "2025-09-05",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-09-05",
    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page (\"483 Issued 09/05/2025\")",
    "url": "https://www.fda.gov/media/189926/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "regulatory_meeting",
    "date": "2023-01-31",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Regulatory Meeting Held 01/31/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Farmakeio Outsourcing LLC, Southlake, TX - 503B Facility"
   },
   {
    "type": "483",
    "date": "2022-06-14",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Amended 483 Issued 6/14/2022 (PDF - 938 KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/161527/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Farmakeio Outsourcing LLC, Southlake, TX - 503B Facility"
   },
   {
    "type": "warning_letter",
    "date": "2021-07-29",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter (07/29/2021)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/farmakeio-outsourcing-llc-608257-07292021",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Farmakeio Outsourcing LLC, Southlake, TX - 503B Facility"
   },
   {
    "type": "483",
    "date": "2019-10-30",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 10/30/2019 (PDF - 2.76MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/139181/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Farmakeio Outsourcing LLC, Southlake, TX - 503B Facility"
   }
  ],
  "counts": {
   "form483": 3,
   "warning_letters": 1,
   "recalls": 1,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Texas State Board of Pharmacy License Verification",
   "url": "https://www.pharmacy.texas.gov/dbsearch/phy_search.asp",
   "kind": "license lookup"
  },
  "state_name": "Texas"
 },
 {
  "listed_as": "Fagron Compounding Services dba Fagron Sterile Services, Wichita, KS",
  "name": "Fagron Compounding Services dba Fagron Sterile Services",
  "city": "Wichita",
  "state": "KS",
  "phone": "1-316-773-0405",
  "initial_registration": "10/2/2015",
  "initial_registration_date": "2015-10-02",
  "recent_registration": "11/21/2025",
  "recent_registration_date": "2025-11-21",
  "last_inspection": "8/8/2025",
  "last_inspection_date": "2025-08-08",
  "form483_issued": "483",
  "form483_links": [
   {
    "text": "483",
    "url": "https://www.fda.gov/media/188683/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Regulatory Meeting Held 2/27/2026",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "fagron-compounding-services-dba-fagron-sterile-services-wichita-ks",
  "aliases": [
   "Fagron Compounding Services",
   "Fagron Sterile Services"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Fagron Compounding Services LLC (dba Fagron Sterile Services), Wichita, KS - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "98636",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Fagron Compounding Services",
    "firm_city": "Wichita",
    "firm_state": "KS",
    "date": "2026-03-20",
    "report_date": "2026-04-15",
    "classification_date": "2026-04-07",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port"
    ],
    "recall_numbers": [
     "D-0438-2026",
     "D-0439-2026",
     "D-0440-2026",
     "D-0441-2026",
     "D-0442-2026"
    ],
    "products": [
     "Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01",
     "Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01",
     "norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02",
     "norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02",
     "Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2298636%22&limit=100",
    "classification": "Class II",
    "product_count": 5,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "98040",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Fagron Compounding Services",
    "firm_city": "Wichita",
    "firm_state": "KS",
    "date": "2025-11-20",
    "report_date": "2025-12-17",
    "classification_date": "2025-12-08",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Incorrect Product Formulation"
    ],
    "recall_numbers": [
     "D-0221-2026"
    ],
    "products": [
     "Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only.  Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226.  NDC: "
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2298040%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "97540",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Fagron Compounding Services",
    "firm_city": "Wichita",
    "firm_state": "KS",
    "date": "2025-08-29",
    "report_date": "2025-09-24",
    "classification_date": "2025-09-12",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0646-2025"
    ],
    "products": [
     "bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297540%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "96232",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Fagron Compounding Services",
    "firm_city": "Wichita",
    "firm_state": "KS",
    "date": "2025-01-31",
    "report_date": "2025-02-26",
    "classification_date": "2025-02-19",
    "status": "Completed",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0225-2025"
    ],
    "products": [
     "fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use  100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296232%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "95146",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Fagron Compounding Services",
    "firm_city": "Wichita",
    "firm_state": "KS",
    "date": "2024-08-15",
    "report_date": "2024-08-28",
    "classification_date": "2024-08-16",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0636-2024"
    ],
    "products": [
     "Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2295146%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "93453",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Fagron Compounding Services",
    "firm_city": "Wichita",
    "firm_state": "KS",
    "date": "2023-11-10",
    "report_date": "2023-12-06",
    "classification_date": "2023-11-28",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper"
    ],
    "recall_numbers": [
     "D-0125-2024"
    ],
    "products": [
     "Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Use Only, Not for IV Use, This is a Compounded Drug, Hospital & Office Use Only, Fagron Steri"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293453%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "80383",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Fagron Compounding Services LLC dba Fagron Sterile Services",
    "firm_city": "Wichita",
    "firm_state": "KS",
    "date": "2018-06-29",
    "report_date": "2018-07-11",
    "classification_date": "2018-07-06",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL."
    ],
    "recall_numbers": [
     "D-0910-2018",
     "D-0911-2018"
    ],
    "products": [
     "Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS  67205, NDC 71266-2003-02.",
     "Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS  67205, NDC 71266-2003-01."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2280383%22&limit=100",
    "classification": "Class I",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "77584",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Fagron Compounding Services LLC dba Fagron Sterile Services",
    "firm_city": "Wichita",
    "firm_state": "KS",
    "date": "2017-06-19",
    "report_date": "2017-07-12",
    "classification_date": "2017-07-06",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier"
    ],
    "recall_numbers": [
     "D-0946-2017"
    ],
    "products": [
     "Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe.  IV Use Only. JCB Laboratories, 8710 E 34th St., N. Wichita, KS 67226 UPC 7335968405"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2277584%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "recall",
    "event_id": "98636",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Fagron Compounding Services",
    "firm_city": "Wichita",
    "firm_state": "KS",
    "date": "2026-03-20",
    "report_date": "2026-04-15",
    "classification_date": "2026-04-07",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port"
    ],
    "recall_numbers": [
     "D-0438-2026",
     "D-0439-2026",
     "D-0440-2026",
     "D-0441-2026",
     "D-0442-2026"
    ],
    "products": [
     "Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01",
     "Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01",
     "norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02",
     "norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02",
     "Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2298636%22&limit=100",
    "classification": "Class II",
    "product_count": 5,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "regulatory_meeting",
    "date": "2026-02-27",
    "match": "table",
    "text": "Regulatory Meeting Held 2/27/2026",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "recall",
    "event_id": "98040",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Fagron Compounding Services",
    "firm_city": "Wichita",
    "firm_state": "KS",
    "date": "2025-11-20",
    "report_date": "2025-12-17",
    "classification_date": "2025-12-08",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Incorrect Product Formulation"
    ],
    "recall_numbers": [
     "D-0221-2026"
    ],
    "products": [
     "Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only.  Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226.  NDC: "
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2298040%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "97540",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Fagron Compounding Services",
    "firm_city": "Wichita",
    "firm_state": "KS",
    "date": "2025-08-29",
    "report_date": "2025-09-24",
    "classification_date": "2025-09-12",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0646-2025"
    ],
    "products": [
     "bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297540%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "inspection",
    "date": "2025-08-08",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: 483",
    "url": "https://www.fda.gov/media/188683/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-08-08",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/188683/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "recall",
    "event_id": "96232",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Fagron Compounding Services",
    "firm_city": "Wichita",
    "firm_state": "KS",
    "date": "2025-01-31",
    "report_date": "2025-02-26",
    "classification_date": "2025-02-19",
    "status": "Completed",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0225-2025"
    ],
    "products": [
     "fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use  100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296232%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "warning_letter",
    "date": "2024-12-19",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter (12/19/2024)",
    "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fagron-compounding-services-llc-dba-fagron-sterile-service-698861-12192024",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Fagron Compounding Services LLC (dba Fagron Sterile Services), Wichita, KS - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "95146",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Fagron Compounding Services",
    "firm_city": "Wichita",
    "firm_state": "KS",
    "date": "2024-08-15",
    "report_date": "2024-08-28",
    "classification_date": "2024-08-16",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0636-2024"
    ],
    "products": [
     "Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2295146%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2024-06-28",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 06/28/2024 (PDF - 14 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/182250/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Fagron Compounding Services LLC (dba Fagron Sterile Services), Wichita, KS - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "93453",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Fagron Compounding Services",
    "firm_city": "Wichita",
    "firm_state": "KS",
    "date": "2023-11-10",
    "report_date": "2023-12-06",
    "classification_date": "2023-11-28",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper"
    ],
    "recall_numbers": [
     "D-0125-2024"
    ],
    "products": [
     "Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Use Only, Not for IV Use, This is a Compounded Drug, Hospital & Office Use Only, Fagron Steri"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293453%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "fmd145_letter",
    "date": "2022-11-21",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 11/21/2022",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Fagron Compounding Services LLC (dba Fagron Sterile Services), Wichita, KS - 503B Facility"
   },
   {
    "type": "483",
    "date": "2022-03-24",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 03/24/2022 (PDF - 7 MB)",
    "url": "https://www.fda.gov/media/161627/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Fagron Compounding Services LLC (dba Fagron Sterile Services), Wichita, KS - 503B Facility"
   },
   {
    "type": "483",
    "date": "2019-06-21",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 06/21/2019 (PDF - 2 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/130443/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Fagron Compounding Services LLC (dba Fagron Sterile Services), Wichita, KS - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "80383",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Fagron Compounding Services LLC dba Fagron Sterile Services",
    "firm_city": "Wichita",
    "firm_state": "KS",
    "date": "2018-06-29",
    "report_date": "2018-07-11",
    "classification_date": "2018-07-06",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL."
    ],
    "recall_numbers": [
     "D-0910-2018",
     "D-0911-2018"
    ],
    "products": [
     "Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS  67205, NDC 71266-2003-02.",
     "Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS  67205, NDC 71266-2003-01."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2280383%22&limit=100",
    "classification": "Class I",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "77584",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Fagron Compounding Services LLC dba Fagron Sterile Services",
    "firm_city": "Wichita",
    "firm_state": "KS",
    "date": "2017-06-19",
    "report_date": "2017-07-12",
    "classification_date": "2017-07-06",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier"
    ],
    "recall_numbers": [
     "D-0946-2017"
    ],
    "products": [
     "Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe.  IV Use Only. JCB Laboratories, 8710 E 34th St., N. Wichita, KS 67226 UPC 7335968405"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2277584%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "counts": {
   "form483": 4,
   "warning_letters": 1,
   "recalls": 8,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Kansas State Board of Pharmacy",
   "url": "https://pharmacy.ks.gov/",
   "kind": "board site"
  },
  "state_name": "Kansas"
 },
 {
  "listed_as": "Fresenius Kabi Compounding LLC dba Fagron Sterile Services, Canton, MA",
  "name": "Fresenius Kabi Compounding LLC dba Fagron Sterile Services",
  "city": "Canton",
  "state": "MA",
  "phone": "1-978-810-7318",
  "initial_registration": "4/21/2017",
  "initial_registration_date": "2017-04-21",
  "recent_registration": "11/22/2025",
  "recent_registration_date": "2025-11-22",
  "last_inspection": "11/5/2025",
  "last_inspection_date": "2025-11-05",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/190645/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Warning Letter Issued 5/12/2026",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "fresenius-kabi-compounding-llc-dba-fagron-sterile-services-canton-ma",
  "aliases": [
   "Fresenius Kabi Compounding LLC",
   "Fagron Sterile Services"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Fresenius Kabi Compounding, LLC, Canton, MA - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "98391",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Fresenius Kabi Compounding, LLC",
    "firm_city": "Canton",
    "firm_state": "MA",
    "date": "2026-02-05",
    "report_date": "2026-02-18",
    "classification_date": "2026-02-13",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0333-2026",
     "D-0334-2026",
     "D-0335-2026",
     "D-0336-2026",
     "D-0337-2026"
    ],
    "products": [
     "thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.",
     "ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56",
     "vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59",
     "vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.",
     "acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2298391%22&limit=100",
    "classification": "Class II",
    "product_count": 5,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "95427",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Fresenius Kabi Compounding, LLC",
    "firm_city": "Canton",
    "firm_state": "MA",
    "date": "2024-09-25",
    "report_date": "2024-10-30",
    "classification_date": "2024-10-21",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "cGMP violations",
     "CGMP violations"
    ],
    "recall_numbers": [
     "D-0014-2025",
     "D-0015-2025",
     "D-0016-2025",
     "D-0017-2025",
     "D-0018-2025",
     "D-0019-2025",
     "D-0020-2025",
     "D-0021-2025",
     "D-0022-2025",
     "D-0023-2025"
    ],
    "products": [
     "NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58",
     "Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58",
     "EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58",
     "Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59",
     "NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2295427%22&limit=100",
    "classification": "Class II",
    "product_count": 10,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "warning_letter",
    "date": "2026-05-12",
    "match": "table",
    "text": "Warning Letter Issued 5/12/2026",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "recall",
    "event_id": "98391",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Fresenius Kabi Compounding, LLC",
    "firm_city": "Canton",
    "firm_state": "MA",
    "date": "2026-02-05",
    "report_date": "2026-02-18",
    "classification_date": "2026-02-13",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
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     "D-0333-2026",
     "D-0334-2026",
     "D-0335-2026",
     "D-0336-2026",
     "D-0337-2026"
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    "products": [
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     "vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59",
     "vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.",
     "acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2298391%22&limit=100",
    "classification": "Class II",
    "product_count": 5,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "inspection",
    "date": "2025-11-05",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/190645/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-11-05",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/190645/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "recall",
    "event_id": "95427",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Fresenius Kabi Compounding, LLC",
    "firm_city": "Canton",
    "firm_state": "MA",
    "date": "2024-09-25",
    "report_date": "2024-10-30",
    "classification_date": "2024-10-21",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
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     "CGMP violations"
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    "recall_numbers": [
     "D-0014-2025",
     "D-0015-2025",
     "D-0016-2025",
     "D-0017-2025",
     "D-0018-2025",
     "D-0019-2025",
     "D-0020-2025",
     "D-0021-2025",
     "D-0022-2025",
     "D-0023-2025"
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    "products": [
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     "Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58",
     "EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58",
     "Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59",
     "NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2295427%22&limit=100",
    "classification": "Class II",
    "product_count": 10,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "fmd145_letter",
    "date": "2023-08-11",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 08/11/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Fresenius Kabi Compounding, LLC, Canton, MA - 503B Facility"
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   {
    "type": "483",
    "date": "2023-03-06",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 03/06/2023 (PDF - 494KB)",
    "url": "https://www.fda.gov/media/170140/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Fresenius Kabi Compounding, LLC, Canton, MA - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2020-04-22",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 04/22/2020 (PDF - 88KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/139011/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Fresenius Kabi Compounding, LLC, Canton, MA - 503B Facility"
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  ],
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   "warning_letters": 1,
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   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Massachusetts Board of Registration in Pharmacy",
   "url": "https://www.mass.gov/orgs/board-of-registration-in-pharmacy",
   "kind": "board site"
  },
  "state_name": "Massachusetts"
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 {
  "listed_as": "Galaxy Pharmaceuticals, LLC, Albany, NY",
  "name": "Galaxy Pharmaceuticals, LLC",
  "city": "Albany",
  "state": "NY",
  "phone": "1-646-957-7762",
  "initial_registration": "1/26/2024",
  "initial_registration_date": "2024-01-26",
  "recent_registration": "11/26/2025",
  "recent_registration_date": "2025-11-26",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
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   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "NYSED Office of the Professions Verification Search (Pharmacy)",
   "url": "https://eservices.nysed.gov/professions/verification-search",
   "kind": "license lookup"
  },
  "state_name": "New York"
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 {
  "listed_as": "GenoGenix LLC, Raton, FL",
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  "city": "Raton",
  "state": "FL",
  "phone": "1-561-264-7303",
  "initial_registration": "2/4/2025",
  "initial_registration_date": "2025-02-04",
  "recent_registration": "2/11/2026",
  "recent_registration_date": "2026-02-11",
  "last_inspection": "7/18/2025",
  "last_inspection_date": "2025-07-18",
  "form483_issued": "Yes",
  "form483_links": [],
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  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "genogenix-llc-raton-fl",
  "aliases": [
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  "actions_page_entries": [
   {
    "heading": "GenoGenix, LLC, Boca Raton, FL - 503B Facility",
    "match": "uncertain",
    "match_reason": "Name and state match; city listed as 'Boca Raton' vs 'Raton' in FDA's registration table"
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  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "97369",
    "match": "uncertain",
    "match_reason": "Name and state match; city listed as 'Boca Raton' vs 'Raton' in FDA's registration table",
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    "report_date": "2025-10-15",
    "classification_date": "2025-10-21",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility",
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     "D-0039-2026",
     "D-0040-2026",
     "D-0041-2026",
     "D-0042-2026",
     "D-0043-2026",
     "D-0044-2026",
     "D-0045-2026",
     "D-0046-2026",
     "D-0047-2026",
     "D-0048-2026",
     "D-0049-2026",
     "D-0050-2026",
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     "D-0052-2026",
     "D-0053-2026",
     "D-0054-2026",
     "D-0055-2026",
     "D-0056-2026",
     "D-0057-2026",
     "D-0058-2026",
     "D-0059-2026",
     "D-0060-2026",
     "D-0061-2026",
     "D-0062-2026",
     "D-0063-2026",
     "D-0064-2026",
     "D-0065-2026",
     "D-0066-2026",
     "D-0067-2026",
     "D-0068-2026",
     "D-0069-2026",
     "D-0070-2026",
     "D-0071-2026",
     "D-0072-2026",
     "D-0073-2026",
     "D-0074-2026",
     "D-0075-2026",
     "D-0076-2026",
     "D-0077-2026",
     "D-0078-2026",
     "D-0079-2026",
     "D-0080-2026",
     "D-0081-2026",
     "D-0082-2026",
     "D-0083-2026",
     "D-0084-2026",
     "D-0085-2026",
     "D-0086-2026",
     "D-0087-2026",
     "D-0088-2026",
     "D-0089-2026",
     "D-0090-2026",
     "D-0091-2026",
     "D-0092-2026",
     "D-0093-2026",
     "D-0094-2026"
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    "products": [
     "Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL",
     "Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692",
     "GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.",
     "Magnesium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.",
     "Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297369%22&limit=100",
    "classification": "Class I, Class II",
    "product_count": 57,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "warning_letter",
    "date": "2026-01-20",
    "match": "uncertain",
    "match_reason": "Name and state match; city listed as 'Boca Raton' vs 'Raton' in FDA's registration table",
    "text": "Warning Letter (01/20/2026)",
    "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/genogenix-llc-718739-01202026",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "GenoGenix, LLC, Boca Raton, FL - 503B Facility"
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    "match_reason": "Name and state match; city listed as 'Boca Raton' vs 'Raton' in FDA's registration table",
    "recalling_firm": "GenoGenix  LLC",
    "firm_city": "Boca Raton",
    "firm_state": "FL",
    "date": "2025-07-30",
    "report_date": "2025-10-15",
    "classification_date": "2025-10-21",
    "status": "Ongoing",
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     "Microbial Contamination of Sterile Products: elevated endotoxin levels"
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     "D-0042-2026",
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     "D-0045-2026",
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     "D-0055-2026",
     "D-0056-2026",
     "D-0057-2026",
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     "D-0059-2026",
     "D-0060-2026",
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     "D-0065-2026",
     "D-0066-2026",
     "D-0067-2026",
     "D-0068-2026",
     "D-0069-2026",
     "D-0070-2026",
     "D-0071-2026",
     "D-0072-2026",
     "D-0073-2026",
     "D-0074-2026",
     "D-0075-2026",
     "D-0076-2026",
     "D-0077-2026",
     "D-0078-2026",
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     "D-0080-2026",
     "D-0081-2026",
     "D-0082-2026",
     "D-0083-2026",
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     "D-0085-2026",
     "D-0086-2026",
     "D-0087-2026",
     "D-0088-2026",
     "D-0089-2026",
     "D-0090-2026",
     "D-0091-2026",
     "D-0092-2026",
     "D-0093-2026",
     "D-0094-2026"
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     "Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297369%22&limit=100",
    "classification": "Class I, Class II",
    "product_count": 57,
    "source": "openFDA drug enforcement API"
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    "type": "inspection",
    "date": "2025-07-18",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-07-18",
    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page (\"Amended 483 Issued 07/18/2025 (PDF - 4.7MB)\"). That listing is an uncertain match: Name and state match; city listed as 'Boca Raton' vs 'Raton' in FDA's registration table",
    "url": "https://www.fda.gov/media/188559/download",
    "source": "FDA registered outsourcing facilities table"
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  ],
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   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 2
  },
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  "board": {
   "name": "Florida Department of Health License Verification (Board of Pharmacy)",
   "url": "https://mqa-internet.doh.state.fl.us/MQASearchServices/Home",
   "kind": "license lookup"
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  "state_name": "Florida"
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 {
  "listed_as": "GFC Pharma, LLC, Westminster, MD",
  "name": "GFC Pharma, LLC",
  "city": "Westminster",
  "state": "MD",
  "phone": "215-264-9995",
  "initial_registration": "12/16/2024",
  "initial_registration_date": "2024-12-16",
  "recent_registration": "12/30/2025",
  "recent_registration_date": "2025-12-30",
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  "last_inspection_date": null,
  "form483_issued": "N/A",
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  "recall_conducted": "N/A",
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  "action_links": [],
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  "slug": "gfc-pharma-llc-westminster-md",
  "aliases": [
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  "actions_page_entries": [],
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   "recalls": 0,
   "uncertain_items": 0
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  "recent_wl_or_recall": false,
  "board": {
   "name": "Maryland Board of Pharmacy",
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   "kind": "board site"
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  "state_name": "Maryland"
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 {
  "listed_as": "Healthwealth Pharmacy, LLC, Houston, TX",
  "name": "Healthwealth Pharmacy, LLC",
  "city": "Houston",
  "state": "TX",
  "phone": "1-713-360-9788",
  "initial_registration": "7/21/2026",
  "initial_registration_date": "2026-07-21",
  "recent_registration": "7/21/2026",
  "recent_registration_date": "2026-07-21",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "healthwealth-pharmacy-llc-houston-tx",
  "aliases": [
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  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
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   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Texas State Board of Pharmacy License Verification",
   "url": "https://www.pharmacy.texas.gov/dbsearch/phy_search.asp",
   "kind": "license lookup"
  },
  "state_name": "Texas"
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 {
  "listed_as": "Hyalo Technologies Limited Liability Company, Somerset, NJ",
  "name": "Hyalo Technologies Limited Liability Company",
  "city": "Somerset",
  "state": "NJ",
  "phone": "1-908-399-3600",
  "initial_registration": "5/1/2025",
  "initial_registration_date": "2025-05-01",
  "recent_registration": "12/3/2025",
  "recent_registration_date": "2025-12-03",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
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  "slug": "hyalo-technologies-limited-liability-company-somerset-nj",
  "aliases": [
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  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "New Jersey Board of Pharmacy License Verification",
   "url": "https://newjersey.mylicense.com/verification/",
   "kind": "license lookup"
  },
  "state_name": "New Jersey"
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 {
  "listed_as": "Hybrid Pharma, LLC, Deerfield Beach, CA",
  "name": "Hybrid Pharma, LLC",
  "city": "Deerfield Beach",
  "state": "CA",
  "phone": "954-708-2771",
  "initial_registration": "1/14/2015",
  "initial_registration_date": "2015-01-14",
  "recent_registration": "12/16/2025",
  "recent_registration_date": "2025-12-16",
  "last_inspection": "8/27/2026",
  "last_inspection_date": "2026-08-27",
  "form483_issued": "Yes",
  "form483_links": [],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "hybrid-pharma-llc-deerfield-beach-ca",
  "aliases": [
   "Hybrid Pharma, LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Hybrid Pharma LLC, Deerfield Beach, FL - 503B Facility",
    "match": "uncertain",
    "match_reason": "Name and city match but state differs (FL vs CA); possible typo in a source"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-08-27",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-08-27",
    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table (no document link published there)",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2023-11-09",
    "match": "uncertain",
    "match_reason": "Name and city match but state differs (FL vs CA); possible typo in a source",
    "text": "483 Issued 11/09/2023 (PDF - 15MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/175704/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Hybrid Pharma LLC, Deerfield Beach, FL - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2023-07-10",
    "match": "uncertain",
    "match_reason": "Name and city match but state differs (FL vs CA); possible typo in a source",
    "text": "FMD-145 Letter Issued 07/10/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Hybrid Pharma LLC, Deerfield Beach, FL - 503B Facility"
   },
   {
    "type": "warning_letter",
    "date": "2022-06-07",
    "match": "uncertain",
    "match_reason": "Name and city match but state differs (FL vs CA); possible typo in a source",
    "text": "Warning Letter (06/07/2022)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hybrid-pharma-llc-629021-06072022",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Hybrid Pharma LLC, Deerfield Beach, FL - 503B Facility"
   },
   {
    "type": "483",
    "date": "2021-09-03",
    "match": "uncertain",
    "match_reason": "Name and city match but state differs (FL vs CA); possible typo in a source",
    "text": "483 Issued 09/03/2021 (PDF - 1.42MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/158758/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Hybrid Pharma LLC, Deerfield Beach, FL - 503B Facility"
   },
   {
    "type": "483",
    "date": "2019-06-24",
    "match": "uncertain",
    "match_reason": "Name and city match but state differs (FL vs CA); possible typo in a source",
    "text": "Amended 483 Issued 06/24/2019 (PDF - 1.4MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/130512/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Hybrid Pharma LLC, Deerfield Beach, FL - 503B Facility"
   }
  ],
  "counts": {
   "form483": 1,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 5
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "California State Board of Pharmacy (DCA License Search)",
   "url": "https://search.dca.ca.gov/",
   "kind": "license lookup"
  },
  "state_name": "California"
 },
 {
  "listed_as": "Imprimis NJOF, LLC, Ledgewood, NJ",
  "name": "Imprimis NJOF, LLC",
  "city": "Ledgewood",
  "state": "NJ",
  "phone": "973-328-8756",
  "initial_registration": "11/12/2016",
  "initial_registration_date": "2016-11-12",
  "recent_registration": "11/26/2025",
  "recent_registration_date": "2025-11-26",
  "last_inspection": "8/18/2026",
  "last_inspection_date": "2026-08-18",
  "form483_issued": "Yes",
  "form483_links": [],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "imprimis-njof-llc-ledgewood-nj",
  "aliases": [
   "Imprimis NJOF, LLC"
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  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Imprimis NJOF, LLC, Ledgewood, NJ - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
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  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "98181",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2025-12-18",
    "report_date": "2026-01-14",
    "classification_date": "2026-01-02",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of particulate matter - Glass like particles."
    ],
    "recall_numbers": [
     "D-0249-2026",
     "D-0250-2026",
     "D-0251-2026"
    ],
    "products": [
     "Tri-Moxi+\u00bf  (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.",
     "Dexamethasone  Moxifloxacin  Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.",
     "Dexamethasone   Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2298181%22&limit=100",
    "classification": "Class II",
    "product_count": 3,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "97824",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2025-10-20",
    "report_date": "2025-11-26",
    "classification_date": "2025-11-17",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug"
    ],
    "recall_numbers": [
     "D-0157-2026"
    ],
    "products": [
     "Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottle, Rx only, Mfg by: Imprimis NJOF, LLC, 1705 Route 46 West, Ledgewood, NJ 07852, NDC 71384-514-05"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297824%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "97183",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2025-07-09",
    "report_date": "2025-07-30",
    "classification_date": "2025-07-21",
    "status": "Completed",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Sub-Potent Drug: Subpotent assay results during stability testing."
    ],
    "recall_numbers": [
     "D-0535-2025",
     "D-0536-2025"
    ],
    "products": [
     "Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.",
     "Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705  Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297183%22&limit=100",
    "classification": "Class II, Class III",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "96329",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2025-02-24",
    "report_date": "2025-04-09",
    "classification_date": "2025-03-28",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim."
    ],
    "recall_numbers": [
     "D-0305-2025"
    ],
    "products": [
     "Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5%  2.5%  0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296329%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "94552",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2024-05-14",
    "report_date": "2024-06-19",
    "classification_date": "2024-06-07",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0548-2024"
    ],
    "products": [
     "Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 71384-310-05"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2294552%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "94551",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2024-05-14",
    "report_date": "2024-06-05",
    "classification_date": "2024-05-29",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0512-2024",
     "D-0513-2024",
     "D-0514-2024",
     "D-0515-2024",
     "D-0516-2024"
    ],
    "products": [
     "Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01",
     "Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08",
     "Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08",
     "Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-512-01",
     "Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2294551%22&limit=100",
    "classification": "Class II",
    "product_count": 5,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "94553",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2024-05-14",
    "report_date": "2024-06-05",
    "classification_date": "2024-05-30",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0519-2024"
    ],
    "products": [
     "Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2294553%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "94554",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2024-05-14",
    "report_date": "2024-06-19",
    "classification_date": "2024-06-07",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0547-2024"
    ],
    "products": [
     "Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OFFICE USE ONLY  Compounded by: Imprimis NJOF, LLC., 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852 NDC"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2294554%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "94378",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2024-04-10",
    "report_date": "2024-05-08",
    "classification_date": "2024-04-29",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug"
    ],
    "recall_numbers": [
     "D-0476-2024"
    ],
    "products": [
     "Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2294378%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "94372",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2024-04-10",
    "report_date": "2024-05-08",
    "classification_date": "2024-04-30",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Out of specification for assay"
    ],
    "recall_numbers": [
     "D-0478-2024"
    ],
    "products": [
     "Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free,  1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2294372%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "93160",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2023-10-03",
    "report_date": "2023-10-11",
    "classification_date": "2023-10-05",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent: Failing Test Results for Epinephrine"
    ],
    "recall_numbers": [
     "D-0040-2024"
    ],
    "products": [
     "Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01  Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023  Expires on: 17APR2024. In case of adverse"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293160%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "93093",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2023-09-20",
    "report_date": "2023-10-25",
    "classification_date": "2023-10-13",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim."
    ],
    "recall_numbers": [
     "D-0043-2024"
    ],
    "products": [
     "MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293093%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "92848",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2023-08-10",
    "report_date": "2023-08-30",
    "classification_date": "2023-08-21",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range."
    ],
    "recall_numbers": [
     "D-1094-2023"
    ],
    "products": [
     "Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2292848%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "87029",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2020-12-17",
    "report_date": "2021-01-06",
    "classification_date": "2020-12-30",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of assurance of sterility: 13 vials were discovered to have faulty crimps."
    ],
    "recall_numbers": [
     "D-0177-2021"
    ],
    "products": [
     "Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ - 07852 (844)446-6979"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2287029%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-08-18",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-08-18",
    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table (no document link published there)",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "recall",
    "event_id": "98181",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2025-12-18",
    "report_date": "2026-01-14",
    "classification_date": "2026-01-02",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of particulate matter - Glass like particles."
    ],
    "recall_numbers": [
     "D-0249-2026",
     "D-0250-2026",
     "D-0251-2026"
    ],
    "products": [
     "Tri-Moxi+\u00bf  (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.",
     "Dexamethasone  Moxifloxacin  Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.",
     "Dexamethasone   Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2298181%22&limit=100",
    "classification": "Class II",
    "product_count": 3,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "97824",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2025-10-20",
    "report_date": "2025-11-26",
    "classification_date": "2025-11-17",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug"
    ],
    "recall_numbers": [
     "D-0157-2026"
    ],
    "products": [
     "Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottle, Rx only, Mfg by: Imprimis NJOF, LLC, 1705 Route 46 West, Ledgewood, NJ 07852, NDC 71384-514-05"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297824%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "97183",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2025-07-09",
    "report_date": "2025-07-30",
    "classification_date": "2025-07-21",
    "status": "Completed",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Sub-Potent Drug: Subpotent assay results during stability testing."
    ],
    "recall_numbers": [
     "D-0535-2025",
     "D-0536-2025"
    ],
    "products": [
     "Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.",
     "Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705  Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297183%22&limit=100",
    "classification": "Class II, Class III",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "96329",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2025-02-24",
    "report_date": "2025-04-09",
    "classification_date": "2025-03-28",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim."
    ],
    "recall_numbers": [
     "D-0305-2025"
    ],
    "products": [
     "Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5%  2.5%  0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296329%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "94552",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2024-05-14",
    "report_date": "2024-06-19",
    "classification_date": "2024-06-07",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0548-2024"
    ],
    "products": [
     "Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 71384-310-05"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2294552%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "94551",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2024-05-14",
    "report_date": "2024-06-05",
    "classification_date": "2024-05-29",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0512-2024",
     "D-0513-2024",
     "D-0514-2024",
     "D-0515-2024",
     "D-0516-2024"
    ],
    "products": [
     "Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01",
     "Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08",
     "Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08",
     "Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-512-01",
     "Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2294551%22&limit=100",
    "classification": "Class II",
    "product_count": 5,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "94553",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2024-05-14",
    "report_date": "2024-06-05",
    "classification_date": "2024-05-30",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0519-2024"
    ],
    "products": [
     "Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vial for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2294553%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "94554",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2024-05-14",
    "report_date": "2024-06-19",
    "classification_date": "2024-06-07",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0547-2024"
    ],
    "products": [
     "Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OFFICE USE ONLY  Compounded by: Imprimis NJOF, LLC., 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852 NDC"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2294554%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "94378",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2024-04-10",
    "report_date": "2024-05-08",
    "classification_date": "2024-04-29",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug"
    ],
    "recall_numbers": [
     "D-0476-2024"
    ],
    "products": [
     "Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2294378%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "94372",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2024-04-10",
    "report_date": "2024-05-08",
    "classification_date": "2024-04-30",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Out of specification for assay"
    ],
    "recall_numbers": [
     "D-0478-2024"
    ],
    "products": [
     "Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free,  1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2294372%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2024-04-03",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 04/03/2024 (PDF - 3.21MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/180618/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Imprimis NJOF, LLC, Ledgewood, NJ - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "93160",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2023-10-03",
    "report_date": "2023-10-11",
    "classification_date": "2023-10-05",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent: Failing Test Results for Epinephrine"
    ],
    "recall_numbers": [
     "D-0040-2024"
    ],
    "products": [
     "Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01  Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023  Expires on: 17APR2024. In case of adverse"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293160%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "93093",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2023-09-20",
    "report_date": "2023-10-25",
    "classification_date": "2023-10-13",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim."
    ],
    "recall_numbers": [
     "D-0043-2024"
    ],
    "products": [
     "MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293093%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "92848",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2023-08-10",
    "report_date": "2023-08-30",
    "classification_date": "2023-08-21",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range."
    ],
    "recall_numbers": [
     "D-1094-2023"
    ],
    "products": [
     "Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2292848%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2021-01-29",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 01/29/2021 (PDF - 5.35MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/151431/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Imprimis NJOF, LLC, Ledgewood, NJ - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "87029",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Imprimis NJOF, LLC",
    "firm_city": "Ledgewood",
    "firm_state": "NJ",
    "date": "2020-12-17",
    "report_date": "2021-01-06",
    "classification_date": "2020-12-30",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of assurance of sterility: 13 vials were discovered to have faulty crimps."
    ],
    "recall_numbers": [
     "D-0177-2021"
    ],
    "products": [
     "Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ - 07852 (844)446-6979"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2287029%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "warning_letter",
    "date": "2019-06-07",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter (06/07/2019)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/imprimis-njof-llc-553322-06072019",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Imprimis NJOF, LLC, Ledgewood, NJ - 503B Facility"
   }
  ],
  "counts": {
   "form483": 3,
   "warning_letters": 1,
   "recalls": 14,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "New Jersey Board of Pharmacy License Verification",
   "url": "https://newjersey.mylicense.com/verification/",
   "kind": "license lookup"
  },
  "state_name": "New Jersey"
 },
 {
  "listed_as": "IntegraDose Compounding Services, LLC, Shoreview, MN",
  "name": "IntegraDose Compounding Services, LLC",
  "city": "Shoreview",
  "state": "MN",
  "phone": "1-612-672-6173",
  "initial_registration": "2/13/2026",
  "initial_registration_date": "2026-02-13",
  "recent_registration": "10/7/2026",
  "recent_registration_date": "2026-10-07",
  "last_inspection": "8/12/2026",
  "last_inspection_date": "2026-08-12",
  "form483_issued": "Yes",
  "form483_links": [],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "integradose-compounding-services-llc-shoreview-mn",
  "aliases": [
   "IntegraDose Compounding Services, LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "IntegraDose Compounding Services, LLC, Minneapolis, MN - 503B Facility",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Minneapolis, MN); may be another site of the same company"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "99014",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "IntegraDose Compounding Services LLC",
    "firm_city": "Shoreview",
    "firm_state": "MN",
    "date": "2026-05-18",
    "report_date": "2026-06-24",
    "classification_date": "2026-06-12",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug"
    ],
    "recall_numbers": [
     "D-0593-2026"
    ],
    "products": [
     "Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2299014%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "98991",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "IntegraDose Compounding Services LLC",
    "firm_city": "Shoreview",
    "firm_state": "MN",
    "date": "2026-05-12",
    "report_date": "2026-05-27",
    "classification_date": "2026-05-21",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug"
    ],
    "recall_numbers": [
     "D-0548-2026"
    ],
    "products": [
     "fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC  71139-6030-1."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2298991%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "97641",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Minneapolis, MN); may be another site of the same company",
    "recalling_firm": "IntegraDose Compounding Services LLC",
    "firm_city": "Minneapolis",
    "firm_state": "MN",
    "date": "2025-09-16",
    "report_date": "2025-10-22",
    "classification_date": "2025-10-10",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug: Testing revealed there was no oxytocin in the IV bag."
    ],
    "recall_numbers": [
     "D-0015-2026"
    ],
    "products": [
     "Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842  NDC 71139-0012-1"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297641%22&limit=100",
    "classification": "Class I",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "94275",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Minneapolis, MN); may be another site of the same company",
    "recalling_firm": "IntegraDose Compounding Services LLC",
    "firm_city": "Minneapolis",
    "firm_state": "MN",
    "date": "2024-03-22",
    "report_date": "2024-04-10",
    "classification_date": "2024-04-03",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility: leaking bags"
    ],
    "recall_numbers": [
     "D-0432-2024"
    ],
    "products": [
     "fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2294275%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "93940",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Minneapolis, MN); may be another site of the same company",
    "recalling_firm": "IntegraDose Compounding Services LLC",
    "firm_city": "Minneapolis",
    "firm_state": "MN",
    "date": "2024-01-22",
    "report_date": "2024-02-21",
    "classification_date": "2024-02-15",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date."
    ],
    "recall_numbers": [
     "D-0325-2024"
    ],
    "products": [
     "Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293940%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "93829",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Minneapolis, MN); may be another site of the same company",
    "recalling_firm": "IntegraDose Compounding Services LLC",
    "firm_city": "Minneapolis",
    "firm_state": "MN",
    "date": "2024-01-12",
    "report_date": "2024-01-31",
    "classification_date": "2024-01-22",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug"
    ],
    "recall_numbers": [
     "D-0258-2024"
    ],
    "products": [
     "Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293829%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "88731",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Minneapolis, MN); may be another site of the same company",
    "recalling_firm": "IntegraDose Compounding Services LLC",
    "firm_city": "Minneapolis",
    "firm_state": "MN",
    "date": "2021-09-17",
    "report_date": "2021-10-06",
    "classification_date": "2021-09-30",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of sterility assurance."
    ],
    "recall_numbers": [
     "D-0896-2021",
     "D-0897-2021"
    ],
    "products": [
     "ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1",
     "ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN.  NDC: 71139-7153-1"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2288731%22&limit=100",
    "classification": "Class II",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-08-12",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-08-12",
    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page (\"483 Issued 08/12/2026 (PDF - 1.83MB)\"). That listing is an uncertain match: Name and state match but a different city (Minneapolis, MN); may be another site of the same company",
    "url": "https://www.fda.gov/media/194849/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "recall",
    "event_id": "99014",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "IntegraDose Compounding Services LLC",
    "firm_city": "Shoreview",
    "firm_state": "MN",
    "date": "2026-05-18",
    "report_date": "2026-06-24",
    "classification_date": "2026-06-12",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug"
    ],
    "recall_numbers": [
     "D-0593-2026"
    ],
    "products": [
     "Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2299014%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "98991",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "IntegraDose Compounding Services LLC",
    "firm_city": "Shoreview",
    "firm_state": "MN",
    "date": "2026-05-12",
    "report_date": "2026-05-27",
    "classification_date": "2026-05-21",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug"
    ],
    "recall_numbers": [
     "D-0548-2026"
    ],
    "products": [
     "fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC  71139-6030-1."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2298991%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "fmd145_letter",
    "date": "2026-03-26",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Minneapolis, MN); may be another site of the same company",
    "text": "FMD-145 Letter Issued 3/26/2026",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "IntegraDose Compounding Services, LLC, Minneapolis, MN - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2026-03-25",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Minneapolis, MN); may be another site of the same company",
    "text": "FMD-145 Letter Issued 3/25/2026",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "IntegraDose Compounding Services, LLC, Minneapolis, MN - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "97641",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Minneapolis, MN); may be another site of the same company",
    "recalling_firm": "IntegraDose Compounding Services LLC",
    "firm_city": "Minneapolis",
    "firm_state": "MN",
    "date": "2025-09-16",
    "report_date": "2025-10-22",
    "classification_date": "2025-10-10",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug: Testing revealed there was no oxytocin in the IV bag."
    ],
    "recall_numbers": [
     "D-0015-2026"
    ],
    "products": [
     "Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842  NDC 71139-0012-1"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297641%22&limit=100",
    "classification": "Class I",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2025-07-25",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Minneapolis, MN); may be another site of the same company",
    "text": "483 issued 07/25/2025 (PDF - 1,243 KB)",
    "url": "https://www.fda.gov/media/188467/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "IntegraDose Compounding Services, LLC, Minneapolis, MN - 503B Facility"
   },
   {
    "type": "regulatory_meeting",
    "date": "2024-09-05",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Minneapolis, MN); may be another site of the same company",
    "text": "Regulatory Meeting Held 09/05/2024",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "IntegraDose Compounding Services, LLC, Minneapolis, MN - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "94275",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Minneapolis, MN); may be another site of the same company",
    "recalling_firm": "IntegraDose Compounding Services LLC",
    "firm_city": "Minneapolis",
    "firm_state": "MN",
    "date": "2024-03-22",
    "report_date": "2024-04-10",
    "classification_date": "2024-04-03",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility: leaking bags"
    ],
    "recall_numbers": [
     "D-0432-2024"
    ],
    "products": [
     "fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2294275%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2024-03-01",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Minneapolis, MN); may be another site of the same company",
    "text": "483 Issued 03/01/2024 (PDF - 2.58MB)",
    "url": "https://www.fda.gov/media/183428/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "IntegraDose Compounding Services, LLC, Minneapolis, MN - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "93940",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Minneapolis, MN); may be another site of the same company",
    "recalling_firm": "IntegraDose Compounding Services LLC",
    "firm_city": "Minneapolis",
    "firm_state": "MN",
    "date": "2024-01-22",
    "report_date": "2024-02-21",
    "classification_date": "2024-02-15",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date."
    ],
    "recall_numbers": [
     "D-0325-2024"
    ],
    "products": [
     "Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293940%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "93829",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Minneapolis, MN); may be another site of the same company",
    "recalling_firm": "IntegraDose Compounding Services LLC",
    "firm_city": "Minneapolis",
    "firm_state": "MN",
    "date": "2024-01-12",
    "report_date": "2024-01-31",
    "classification_date": "2024-01-22",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug"
    ],
    "recall_numbers": [
     "D-0258-2024"
    ],
    "products": [
     "Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293829%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "88731",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Minneapolis, MN); may be another site of the same company",
    "recalling_firm": "IntegraDose Compounding Services LLC",
    "firm_city": "Minneapolis",
    "firm_state": "MN",
    "date": "2021-09-17",
    "report_date": "2021-10-06",
    "classification_date": "2021-09-30",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of sterility assurance."
    ],
    "recall_numbers": [
     "D-0896-2021",
     "D-0897-2021"
    ],
    "products": [
     "ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1",
     "ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN.  NDC: 71139-7153-1"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2288731%22&limit=100",
    "classification": "Class II",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2021-08-02",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Minneapolis, MN); may be another site of the same company",
    "text": "483 Issued 08/02/2021 (PDF - 1.12MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/153590/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "IntegraDose Compounding Services, LLC, Minneapolis, MN - 503B Facility"
   },
   {
    "type": "warning_letter",
    "date": "2020-05-06",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Minneapolis, MN); may be another site of the same company",
    "text": "Warning Letter (05/06/2020)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/integradose-compounding-services-llc-592187-05062020",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "IntegraDose Compounding Services, LLC, Minneapolis, MN - 503B Facility"
   }
  ],
  "counts": {
   "form483": 1,
   "warning_letters": 0,
   "recalls": 2,
   "uncertain_items": 12
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Minnesota Board of Pharmacy",
   "url": "https://mn.gov/boards/pharmacy/",
   "kind": "board site"
  },
  "state_name": "Minnesota"
 },
 {
  "listed_as": "Leesar Inc., Fort Myers, FL",
  "name": "Leesar Inc.",
  "city": "Fort Myers",
  "state": "FL",
  "phone": "1-239-939-8925",
  "initial_registration": "4/30/2014",
  "initial_registration_date": "2014-04-30",
  "recent_registration": "11/26/2025",
  "recent_registration_date": "2025-11-26",
  "last_inspection": "9/28/2026",
  "last_inspection_date": "2026-09-28",
  "form483_issued": "Yes",
  "form483_links": [],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "No",
  "slug": "leesar-inc-fort-myers-fl",
  "aliases": [
   "Leesar Inc."
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "LeeSar, Inc., Fort Myers, FL - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-09-28",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-09-28",
    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table (no document link published there)",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "untitled_letter",
    "date": "2025-11-21",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Untitled Letter issued 11/21/2025",
    "url": "https://www.fda.gov/media/191720/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "LeeSar, Inc., Fort Myers, FL - 503B Facility"
   },
   {
    "type": "483",
    "date": "2025-05-09",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 05/09/2025 (PDF - 854KB)",
    "url": "https://www.fda.gov/media/187040/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "LeeSar, Inc., Fort Myers, FL - 503B Facility"
   },
   {
    "type": "untitled_letter",
    "date": "2022-06-17",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Untitled Letter Issued 06/17/2022 (PDF - 7.62 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/163334/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "LeeSar, Inc., Fort Myers, FL - 503B Facility"
   },
   {
    "type": "483",
    "date": "2021-10-29",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 10/29/2021 (PDF - 976KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/156685/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "LeeSar, Inc., Fort Myers, FL - 503B Facility"
   },
   {
    "type": "warning_letter",
    "date": "2020-02-18",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter (02/18/2020)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/leesar-inc-544728-02182020",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "LeeSar, Inc., Fort Myers, FL - 503B Facility"
   }
  ],
  "counts": {
   "form483": 3,
   "warning_letters": 1,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Florida Department of Health License Verification (Board of Pharmacy)",
   "url": "https://mqa-internet.doh.state.fl.us/MQASearchServices/Home",
   "kind": "license lookup"
  },
  "state_name": "Florida"
 },
 {
  "listed_as": "Mark Cuban Cost Plus Manufacturing and Compounding, LLC, Dallas, TX",
  "name": "Mark Cuban Cost Plus Manufacturing and Compounding, LLC",
  "city": "Dallas",
  "state": "TX",
  "phone": "303-907-8003",
  "initial_registration": "11/2/2022",
  "initial_registration_date": "2022-11-02",
  "recent_registration": "12/14/2024",
  "recent_registration_date": "2024-12-14",
  "last_inspection": "9/30/2026",
  "last_inspection_date": "2026-09-30",
  "form483_issued": "Yes",
  "form483_links": [],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "mark-cuban-cost-plus-manufacturing-and-compounding-llc-dallas-tx",
  "aliases": [
   "Mark Cuban Cost Plus Manufacturing and Compounding, LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-09-30",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-09-30",
    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table (no document link published there)",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   }
  ],
  "counts": {
   "form483": 1,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Texas State Board of Pharmacy License Verification",
   "url": "https://www.pharmacy.texas.gov/dbsearch/phy_search.asp",
   "kind": "license lookup"
  },
  "state_name": "Texas"
 },
 {
  "listed_as": "Maxhealth Group, LLC dba New Life Rx, Dallas, TX",
  "name": "Maxhealth Group, LLC dba New Life Rx",
  "city": "Dallas",
  "state": "TX",
  "phone": "1-949-463-9876",
  "initial_registration": "4/29/2026",
  "initial_registration_date": "2026-04-29",
  "recent_registration": "4/29/2026",
  "recent_registration_date": "2026-04-29",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "maxhealth-group-llc-dba-new-life-rx-dallas-tx",
  "aliases": [
   "Maxhealth Group, LLC",
   "New Life Rx"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Texas State Board of Pharmacy License Verification",
   "url": "https://www.pharmacy.texas.gov/dbsearch/phy_search.asp",
   "kind": "license lookup"
  },
  "state_name": "Texas"
 },
 {
  "listed_as": "McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions, Santa Ana, CA",
  "name": "McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions",
  "city": "Santa Ana",
  "state": "CA",
  "phone": "714-918-7277 Ext 314",
  "initial_registration": "1/11/2023",
  "initial_registration_date": "2023-01-11",
  "recent_registration": "12/2/2025",
  "recent_registration_date": "2025-12-02",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "mcguff-pharmaceuticals-inc-dba-mcguff-outsourcing-solutions-santa-ana-ca",
  "aliases": [
   "McGuff Pharmaceuticals, Inc.",
   "McGuff Outsourcing Solutions"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA - 503A Facility",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "fmd145_letter",
    "date": "2020-05-29",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state",
    "text": "FMD-145 Letter Issued 05/29/2020 (PDF - 60KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/139161/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA - 503A Facility"
   },
   {
    "type": "state_referral",
    "date": "2020-05-29",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state",
    "text": "State Referral Letter Issued 05/29/2020",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA - 503A Facility"
   },
   {
    "type": "483",
    "date": "2019-11-22",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state",
    "text": "483 Issued 11/22/2019 (PDF - 978KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/133951/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA - 503A Facility"
   }
  ],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 3
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "California State Board of Pharmacy (DCA License Search)",
   "url": "https://search.dca.ca.gov/",
   "kind": "license lookup"
  },
  "state_name": "California"
 },
 {
  "listed_as": "Medi-Fare Drug, Blacksburg, SC",
  "name": "Medi-Fare Drug",
  "city": "Blacksburg",
  "state": "SC",
  "phone": "1-318-218-3647",
  "initial_registration": "12/17/2013",
  "initial_registration_date": "2013-12-17",
  "recent_registration": "12/31/2025",
  "recent_registration_date": "2025-12-31",
  "last_inspection": "6/6/2025",
  "last_inspection_date": "2025-06-06",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/188091/download?attachment"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "medi-fare-drug-blacksburg-sc",
  "aliases": [
   "Medi-Fare Drug"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Medi-Fare Drug and Pharmaceutical Compounding, LLC, Blacksburg, SC - 503B Facility",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "inspection",
    "date": "2025-06-06",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/188091/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-06-06",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/188091/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "fmd145_letter",
    "date": "2023-10-23",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state",
    "text": "FMD-145 Letter Issued 10/23/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Medi-Fare Drug and Pharmaceutical Compounding, LLC, Blacksburg, SC - 503B Facility"
   },
   {
    "type": "483",
    "date": "2023-05-26",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state",
    "text": "483 Issued 05/26/2023 (PDF - 506 KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/177153/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Medi-Fare Drug and Pharmaceutical Compounding, LLC, Blacksburg, SC - 503B Facility"
   },
   {
    "type": "untitled_letter",
    "date": "2019-03-18",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state",
    "text": "Untitled Letter 03/18/2019 (PDF - 2 8MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/130385/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Medi-Fare Drug and Pharmaceutical Compounding, LLC, Blacksburg, SC - 503B Facility"
   }
  ],
  "counts": {
   "form483": 1,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 3
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "South Carolina LLR License Lookup (Board of Pharmacy)",
   "url": "https://verify.llronline.com/LicLookup/LookupMain.aspx",
   "kind": "license lookup"
  },
  "state_name": "South Carolina"
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 {
  "listed_as": "Medicinal Sciences Ltd. Co., Heath, TX",
  "name": "Medicinal Sciences Ltd. Co.",
  "city": "Heath",
  "state": "TX",
  "phone": "1-972-775-0835",
  "initial_registration": "9/21/2026",
  "initial_registration_date": "2026-09-21",
  "recent_registration": "9/21/2026",
  "recent_registration_date": "2026-09-21",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "medicinal-sciences-ltd-co-heath-tx",
  "aliases": [
   "Medicinal Sciences Ltd. Co."
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
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  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Texas State Board of Pharmacy License Verification",
   "url": "https://www.pharmacy.texas.gov/dbsearch/phy_search.asp",
   "kind": "license lookup"
  },
  "state_name": "Texas"
 },
 {
  "listed_as": "MedisourceRx, Los Alamitos, CA",
  "name": "MedisourceRx",
  "city": "Los Alamitos",
  "state": "CA",
  "phone": "1-714-455-1300",
  "initial_registration": "2/14/2017",
  "initial_registration_date": "2017-02-14",
  "recent_registration": "1/2/2026",
  "recent_registration_date": "2026-01-02",
  "last_inspection": "6/10/2025",
  "last_inspection_date": "2025-06-10",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/187955/download?attachment"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Warning Letter Closeout Issued 7/27/2026 Warning Letter Issued 12/12/2025",
  "action_links": [
   {
    "text": "Warning Letter Issued 12/12/2025",
    "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medisourcerx-717970-12122025"
   }
  ],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "medisourcerx-los-alamitos-ca",
  "aliases": [
   "MedisourceRx"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "MedisourceRx, Los Alamitos, CA - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "warning_letter_closeout",
    "date": "2026-07-27",
    "match": "table",
    "text": "Warning Letter Closeout Issued 7/27/2026",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "warning_letter",
    "date": "2025-12-12",
    "match": "table",
    "text": "Warning Letter Issued 12/12/2025",
    "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medisourcerx-717970-12122025",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "inspection",
    "date": "2025-06-10",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/187955/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-06-10",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/187955/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "fmd145_letter",
    "date": "2023-04-14",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 04/14/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "MedisourceRx, Los Alamitos, CA - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2021-06-28",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 06/28/2021",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "MedisourceRx, Los Alamitos, CA - 503B Facility"
   },
   {
    "type": "483",
    "date": "2020-10-22",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 10/22/2020 (PDF - 1.15MB)",
    "url": "https://www.fda.gov/media/154824/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "MedisourceRx, Los Alamitos, CA - 503B Facility"
   }
  ],
  "counts": {
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   "warning_letters": 1,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "California State Board of Pharmacy (DCA License Search)",
   "url": "https://search.dca.ca.gov/",
   "kind": "license lookup"
  },
  "state_name": "California"
 },
 {
  "listed_as": "Molecular PharmaGroup, New Providence, NJ",
  "name": "Molecular PharmaGroup",
  "city": "New Providence",
  "state": "NJ",
  "phone": "908-588-3440",
  "initial_registration": "5/8/2018",
  "initial_registration_date": "2018-05-08",
  "recent_registration": "12/30/2025",
  "recent_registration_date": "2025-12-30",
  "last_inspection": "8/11/2025",
  "last_inspection_date": "2025-08-11",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/188960/download?attachment"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Untitled Letter Issued 2/5/2026",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "molecular-pharmagroup-new-providence-nj",
  "aliases": [
   "Molecular PharmaGroup"
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  "actions_page_entries": [
   {
    "heading": "Molecular PharmaGroup, LLC, New Providence, NJ - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "fmd145_letter",
    "date": "2026-04-08",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 04/8/2026",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Molecular PharmaGroup, LLC, New Providence, NJ - 503B Facility"
   },
   {
    "type": "untitled_letter",
    "date": "2026-02-05",
    "match": "table",
    "text": "Untitled Letter Issued 2/5/2026; document link from FDA's compounding actions page (\"Untitled Letter Issued 02/05/2026 (PDF - 858 KB)\")",
    "url": "https://www.fda.gov/media/193965/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "inspection",
    "date": "2025-08-11",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/188960/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-08-11",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/188960/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "fmd145_letter",
    "date": "2024-03-18",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 03/18/2024",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Molecular PharmaGroup, LLC, New Providence, NJ - 503B Facility"
   }
  ],
  "counts": {
   "form483": 1,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "New Jersey Board of Pharmacy License Verification",
   "url": "https://newjersey.mylicense.com/verification/",
   "kind": "license lookup"
  },
  "state_name": "New Jersey"
 },
 {
  "listed_as": "Navinta III Inc., Boca Raton, FL",
  "name": "Navinta III Inc.",
  "city": "Boca Raton",
  "state": "FL",
  "phone": "1-561-997-6595",
  "initial_registration": "2/6/2026",
  "initial_registration_date": "2026-02-06",
  "recent_registration": "2/6/2026",
  "recent_registration_date": "2026-02-06",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "navinta-iii-inc-boca-raton-fl",
  "aliases": [
   "Navinta III Inc."
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  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Florida Department of Health License Verification (Board of Pharmacy)",
   "url": "https://mqa-internet.doh.state.fl.us/MQASearchServices/Home",
   "kind": "license lookup"
  },
  "state_name": "Florida"
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 {
  "listed_as": "Nephron Sterile Compounding Center, LLC (NSCC), West Columbia, SC",
  "name": "Nephron Sterile Compounding Center, LLC (NSCC)",
  "city": "West Columbia",
  "state": "SC",
  "phone": "803-569-3110",
  "initial_registration": "7/15/2014",
  "initial_registration_date": "2014-07-15",
  "recent_registration": "12/15/2025",
  "recent_registration_date": "2025-12-15",
  "last_inspection": "8/22/2025",
  "last_inspection_date": "2025-08-22",
  "form483_issued": "483",
  "form483_links": [
   {
    "text": "483",
    "url": "https://www.fda.gov/media/188822/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "nephron-sterile-compounding-center-llc-nscc-west-columbia-sc",
  "aliases": [
   "Nephron Sterile Compounding Center, LLC",
   "NSCC"
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  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Nephron Pharmaceuticals Corporation, dba Nephron Sterile Compounding Center, LLC, West Columbia, SC - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "96419",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nephron Sterile Compounding Center LLC",
    "firm_city": "West Columbia",
    "firm_state": "SC",
    "date": "2025-02-10",
    "report_date": "2025-03-19",
    "classification_date": "2025-03-07",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port."
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    "recall_numbers": [
     "D-0257-2025"
    ],
    "products": [
     "Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296419%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "91749",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nephron Sterile Compounding Center LLC",
    "firm_city": "West Columbia",
    "firm_state": "SC",
    "date": "2023-02-22",
    "report_date": "2023-03-08",
    "classification_date": "2023-02-27",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0355-2023",
     "D-0356-2023",
     "D-0357-2023",
     "D-0358-2023",
     "D-0359-2023",
     "D-0360-2023",
     "D-0361-2023",
     "D-0362-2023"
    ],
    "products": [
     "Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, Wes",
     "Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extensi",
     "Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Co",
     "Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC ",
     "Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, Wes"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291749%22&limit=100",
    "classification": "Class II",
    "product_count": 8,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "91450",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nephron Sterile Compounding Center LLC",
    "firm_city": "West Columbia",
    "firm_state": "SC",
    "date": "2023-01-06",
    "report_date": "2023-01-18",
    "classification_date": "2023-01-09",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0099-2023"
    ],
    "products": [
     "Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291450%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "91132",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nephron Sterile Compounding Center LLC",
    "firm_city": "West Columbia",
    "firm_state": "SC",
    "date": "2022-11-10",
    "report_date": "2022-11-23",
    "classification_date": "2022-11-17",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "CGMP Deviations: Potential for cross contamination due to product carry over."
    ],
    "recall_numbers": [
     "D-0064-2023",
     "D-0065-2023"
    ],
    "products": [
     "PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2.",
     "PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291132%22&limit=100",
    "classification": "Class II",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "90718",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nephron Sterile Compounding Center LLC",
    "firm_city": "West Columbia",
    "firm_state": "SC",
    "date": "2022-08-10",
    "report_date": "2022-08-24",
    "classification_date": "2022-08-16",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing."
    ],
    "recall_numbers": [
     "D-1344-2022",
     "D-1345-2022",
     "D-1346-2022",
     "D-1347-2022"
    ],
    "products": [
     "PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 2",
     "PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 6",
     "PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05",
     "Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Exte"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2290718%22&limit=100",
    "classification": "Class II",
    "product_count": 4,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "90512",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nephron Sterile Compounding Center LLC",
    "firm_city": "West Columbia",
    "firm_state": "SC",
    "date": "2022-06-30",
    "report_date": "2022-07-27",
    "classification_date": "2022-07-18",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-1245-2022",
     "D-1246-2022",
     "D-1247-2022",
     "D-1248-2022",
     "D-1249-2022",
     "D-1250-2022",
     "D-1251-2022",
     "D-1252-2022",
     "D-1253-2022",
     "D-1254-2022",
     "D-1255-2022",
     "D-1256-2022",
     "D-1257-2022",
     "D-1258-2022",
     "D-1259-2022",
     "D-1260-2022",
     "D-1261-2022",
     "D-1262-2022",
     "D-1263-2022",
     "D-1264-2022",
     "D-1265-2022",
     "D-1266-2022",
     "D-1267-2022",
     "D-1268-2022",
     "D-1269-2022",
     "D-1270-2022",
     "D-1271-2022",
     "D-1272-2022",
     "D-1273-2022",
     "D-1274-2022",
     "D-1275-2022",
     "D-1276-2022",
     "D-1277-2022",
     "D-1278-2022",
     "D-1279-2022",
     "D-1280-2022",
     "D-1281-2022"
    ],
    "products": [
     "Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbi",
     "Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Neph",
     "Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), Ketamine HCl 60 mg (1.2 mg/mL) Injection, 50 mL syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 50",
     "8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syringe per carton, 30 x 1 syringe carton per case, Rx Only Nephron 503B outsourcing facility, 4500 12th St. Extension, West C",
     "Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 2917"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2290512%22&limit=100",
    "classification": "Class II",
    "product_count": 37,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "90211",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nephron Sterile Compounding Center LLC",
    "firm_city": "West Columbia",
    "firm_state": "SC",
    "date": "2022-05-18",
    "report_date": "2022-06-08",
    "classification_date": "2022-05-27",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0950-2022",
     "D-0951-2022",
     "D-0952-2022",
     "D-0953-2022",
     "D-0954-2022",
     "D-0955-2022",
     "D-0956-2022",
     "D-0957-2022",
     "D-0958-2022",
     "D-0959-2022",
     "D-0960-2022",
     "D-0961-2022",
     "D-0962-2022",
     "D-0963-2022",
     "D-0964-2022",
     "D-0965-2022",
     "D-0966-2022",
     "D-0967-2022",
     "D-0968-2022",
     "D-0969-2022"
    ],
    "products": [
     "Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, ",
     "Epinephrine Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925",
     "Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69",
     "Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, ",
     "Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 2"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2290211%22&limit=100",
    "classification": "Class II",
    "product_count": 20,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "84106",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center",
    "firm_city": "West Columbia",
    "firm_state": "SC",
    "date": "2019-10-21",
    "report_date": "2019-11-06",
    "classification_date": "2019-10-28",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Incorrect labeling: Incorrect or missing lot and/or exp date"
    ],
    "recall_numbers": [
     "D-0154-2020"
    ],
    "products": [
     "PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron 503B Outsourcing Facility 4500 12th St. Ext West Columbia, SC 29172, NDC 69374-919-10."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2284106%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "83999",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center",
    "firm_city": "West Columbia",
    "firm_state": "SC",
    "date": "2019-10-09",
    "report_date": "2019-10-30",
    "classification_date": "2019-10-18",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility; bags have potential to leak"
    ],
    "recall_numbers": [
     "D-0150-2020",
     "D-0151-2020"
    ],
    "products": [
     "Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172  NDC: 69374-988-10",
     "del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172  NDC: 69374-984-10"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2283999%22&limit=100",
    "classification": "Class II",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "84000",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center",
    "firm_city": "West Columbia",
    "firm_state": "SC",
    "date": "2019-10-09",
    "report_date": "2019-10-30",
    "classification_date": "2019-10-18",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "GMP Deviations: potential glass contamination"
    ],
    "recall_numbers": [
     "D-0147-2020",
     "D-0148-2020",
     "D-0149-2020"
    ],
    "products": [
     "PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only  Total Dose: (500 mcg/312.5 mg)/250 mL, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172  NDC: 69374-5",
     "PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625  in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0",
     "PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172  NDC: 69374-526-20"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2284000%22&limit=100",
    "classification": "Class II",
    "product_count": 3,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "inspection",
    "date": "2025-08-22",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: 483",
    "url": "https://www.fda.gov/media/188822/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-08-22",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/188822/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "recall",
    "event_id": "96419",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nephron Sterile Compounding Center LLC",
    "firm_city": "West Columbia",
    "firm_state": "SC",
    "date": "2025-02-10",
    "report_date": "2025-03-19",
    "classification_date": "2025-03-07",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port."
    ],
    "recall_numbers": [
     "D-0257-2025"
    ],
    "products": [
     "Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, nephron, 503B outsourcing facility, West Columbia, SC 29172, NDC: 69374-334-50"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296419%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2024-09-25",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 09/25/2024 (PDF - 1.35 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/183238/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Nephron Pharmaceuticals Corporation, dba Nephron Sterile Compounding Center, LLC, West Columbia, SC - 503B Facility"
   },
   {
    "type": "regulatory_meeting",
    "date": "2023-11-16",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Regulatory Meeting Held 11/16/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Nephron Pharmaceuticals Corporation, dba Nephron Sterile Compounding Center, LLC, West Columbia, SC - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "91749",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nephron Sterile Compounding Center LLC",
    "firm_city": "West Columbia",
    "firm_state": "SC",
    "date": "2023-02-22",
    "report_date": "2023-03-08",
    "classification_date": "2023-02-27",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0355-2023",
     "D-0356-2023",
     "D-0357-2023",
     "D-0358-2023",
     "D-0359-2023",
     "D-0360-2023",
     "D-0361-2023",
     "D-0362-2023"
    ],
    "products": [
     "Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, Wes",
     "Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extensi",
     "Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Co",
     "Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC ",
     "Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, Wes"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291749%22&limit=100",
    "classification": "Class II",
    "product_count": 8,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2023-02-10",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 02/10/2023 (PDF - 5 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/171873/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Nephron Pharmaceuticals Corporation, dba Nephron Sterile Compounding Center, LLC, West Columbia, SC - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "91450",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nephron Sterile Compounding Center LLC",
    "firm_city": "West Columbia",
    "firm_state": "SC",
    "date": "2023-01-06",
    "report_date": "2023-01-18",
    "classification_date": "2023-01-09",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0099-2023"
    ],
    "products": [
     "Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291450%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "91132",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nephron Sterile Compounding Center LLC",
    "firm_city": "West Columbia",
    "firm_state": "SC",
    "date": "2022-11-10",
    "report_date": "2022-11-23",
    "classification_date": "2022-11-17",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "CGMP Deviations: Potential for cross contamination due to product carry over."
    ],
    "recall_numbers": [
     "D-0064-2023",
     "D-0065-2023"
    ],
    "products": [
     "PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2.",
     "PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291132%22&limit=100",
    "classification": "Class II",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "warning_letter",
    "date": "2022-10-21",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter Issued 10/21/2022",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nephron-pharmaceuticals-corporation-dba-nephron-sterile-compounding-center-llc-644180-10212022",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Nephron Pharmaceuticals Corporation, dba Nephron Sterile Compounding Center, LLC, West Columbia, SC - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "90718",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nephron Sterile Compounding Center LLC",
    "firm_city": "West Columbia",
    "firm_state": "SC",
    "date": "2022-08-10",
    "report_date": "2022-08-24",
    "classification_date": "2022-08-16",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing."
    ],
    "recall_numbers": [
     "D-1344-2022",
     "D-1345-2022",
     "D-1346-2022",
     "D-1347-2022"
    ],
    "products": [
     "PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 2",
     "PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 6",
     "PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05",
     "Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Exte"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2290718%22&limit=100",
    "classification": "Class II",
    "product_count": 4,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "90512",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nephron Sterile Compounding Center LLC",
    "firm_city": "West Columbia",
    "firm_state": "SC",
    "date": "2022-06-30",
    "report_date": "2022-07-27",
    "classification_date": "2022-07-18",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-1245-2022",
     "D-1246-2022",
     "D-1247-2022",
     "D-1248-2022",
     "D-1249-2022",
     "D-1250-2022",
     "D-1251-2022",
     "D-1252-2022",
     "D-1253-2022",
     "D-1254-2022",
     "D-1255-2022",
     "D-1256-2022",
     "D-1257-2022",
     "D-1258-2022",
     "D-1259-2022",
     "D-1260-2022",
     "D-1261-2022",
     "D-1262-2022",
     "D-1263-2022",
     "D-1264-2022",
     "D-1265-2022",
     "D-1266-2022",
     "D-1267-2022",
     "D-1268-2022",
     "D-1269-2022",
     "D-1270-2022",
     "D-1271-2022",
     "D-1272-2022",
     "D-1273-2022",
     "D-1274-2022",
     "D-1275-2022",
     "D-1276-2022",
     "D-1277-2022",
     "D-1278-2022",
     "D-1279-2022",
     "D-1280-2022",
     "D-1281-2022"
    ],
    "products": [
     "Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbi",
     "Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Neph",
     "Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), Ketamine HCl 60 mg (1.2 mg/mL) Injection, 50 mL syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 50",
     "8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syringe per carton, 30 x 1 syringe carton per case, Rx Only Nephron 503B outsourcing facility, 4500 12th St. Extension, West C",
     "Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 2917"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2290512%22&limit=100",
    "classification": "Class II",
    "product_count": 37,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "90211",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nephron Sterile Compounding Center LLC",
    "firm_city": "West Columbia",
    "firm_state": "SC",
    "date": "2022-05-18",
    "report_date": "2022-06-08",
    "classification_date": "2022-05-27",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0950-2022",
     "D-0951-2022",
     "D-0952-2022",
     "D-0953-2022",
     "D-0954-2022",
     "D-0955-2022",
     "D-0956-2022",
     "D-0957-2022",
     "D-0958-2022",
     "D-0959-2022",
     "D-0960-2022",
     "D-0961-2022",
     "D-0962-2022",
     "D-0963-2022",
     "D-0964-2022",
     "D-0965-2022",
     "D-0966-2022",
     "D-0967-2022",
     "D-0968-2022",
     "D-0969-2022"
    ],
    "products": [
     "Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL Pre-Filled Syringe, 5 x 10 Pre-filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, ",
     "Epinephrine Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925",
     "Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69",
     "Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, ",
     "Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 3 mL Pre-Filled Syringe, 5 x 3 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 2"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2290211%22&limit=100",
    "classification": "Class II",
    "product_count": 20,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2022-04-20",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 04/20/2022 (PDF - 3 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/158911/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Nephron Pharmaceuticals Corporation, dba Nephron Sterile Compounding Center, LLC, West Columbia, SC - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2022-04-13",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 04/13/2022",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Nephron Pharmaceuticals Corporation, dba Nephron Sterile Compounding Center, LLC, West Columbia, SC - 503B Facility"
   },
   {
    "type": "483",
    "date": "2019-11-15",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 11/15/2019 (PDF - 2 MB)",
    "url": "https://www.fda.gov/media/137539/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Nephron Pharmaceuticals Corporation, dba Nephron Sterile Compounding Center, LLC, West Columbia, SC - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "84106",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center",
    "firm_city": "West Columbia",
    "firm_state": "SC",
    "date": "2019-10-21",
    "report_date": "2019-11-06",
    "classification_date": "2019-10-28",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Incorrect labeling: Incorrect or missing lot and/or exp date"
    ],
    "recall_numbers": [
     "D-0154-2020"
    ],
    "products": [
     "PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron 503B Outsourcing Facility 4500 12th St. Ext West Columbia, SC 29172, NDC 69374-919-10."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2284106%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "83999",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center",
    "firm_city": "West Columbia",
    "firm_state": "SC",
    "date": "2019-10-09",
    "report_date": "2019-10-30",
    "classification_date": "2019-10-18",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility; bags have potential to leak"
    ],
    "recall_numbers": [
     "D-0150-2020",
     "D-0151-2020"
    ],
    "products": [
     "Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172  NDC: 69374-988-10",
     "del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172  NDC: 69374-984-10"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2283999%22&limit=100",
    "classification": "Class II",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "84000",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center",
    "firm_city": "West Columbia",
    "firm_state": "SC",
    "date": "2019-10-09",
    "report_date": "2019-10-30",
    "classification_date": "2019-10-18",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "GMP Deviations: potential glass contamination"
    ],
    "recall_numbers": [
     "D-0147-2020",
     "D-0148-2020",
     "D-0149-2020"
    ],
    "products": [
     "PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only  Total Dose: (500 mcg/312.5 mg)/250 mL, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172  NDC: 69374-5",
     "PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625  in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0",
     "PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172  NDC: 69374-526-20"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2284000%22&limit=100",
    "classification": "Class II",
    "product_count": 3,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "fmd145_letter",
    "date": "2019-05-17",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 05/17/2019",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Nephron Pharmaceuticals Corporation, dba Nephron Sterile Compounding Center, LLC, West Columbia, SC - 503B Facility"
   }
  ],
  "counts": {
   "form483": 5,
   "warning_letters": 1,
   "recalls": 10,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "South Carolina LLR License Lookup (Board of Pharmacy)",
   "url": "https://verify.llronline.com/LicLookup/LookupMain.aspx",
   "kind": "license lookup"
  },
  "state_name": "South Carolina"
 },
 {
  "listed_as": "Nexgen Formulations, Folcroft, PA",
  "name": "Nexgen Formulations",
  "city": "Folcroft",
  "state": "PA",
  "phone": "1-610-455-5125",
  "initial_registration": "1/15/2026",
  "initial_registration_date": "2026-01-15",
  "recent_registration": "1/15/2026",
  "recent_registration_date": "2026-01-15",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "nexgen-formulations-folcroft-pa",
  "aliases": [
   "Nexgen Formulations"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Pennsylvania Licensing System (PALS) Verification (State Board of Pharmacy)",
   "url": "https://www.pals.pa.gov/",
   "kind": "license lookup"
  },
  "state_name": "Pennsylvania"
 },
 {
  "listed_as": "Nivagen Pharmaceuticals, LLC, Sacramento, CA",
  "name": "Nivagen Pharmaceuticals, LLC",
  "city": "Sacramento",
  "state": "CA",
  "phone": "1-916-591-0160",
  "initial_registration": "3/13/2026",
  "initial_registration_date": "2026-03-13",
  "recent_registration": "3/13/2026",
  "recent_registration_date": "2026-03-13",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "nivagen-pharmaceuticals-llc-sacramento-ca",
  "aliases": [
   "Nivagen Pharmaceuticals, LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [
   {
    "type": "recall",
    "event_id": "95418",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nivagen Pharmaceuticals Inc",
    "firm_city": "Sacramento",
    "firm_state": "CA",
    "date": "2024-09-24",
    "report_date": "2024-10-09",
    "classification_date": "2024-10-02",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg."
    ],
    "recall_numbers": [
     "D-0001-2025"
    ],
    "products": [
     "Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2295418%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "recall",
    "event_id": "95418",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nivagen Pharmaceuticals Inc",
    "firm_city": "Sacramento",
    "firm_state": "CA",
    "date": "2024-09-24",
    "report_date": "2024-10-09",
    "classification_date": "2024-10-02",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg."
    ],
    "recall_numbers": [
     "D-0001-2025"
    ],
    "products": [
     "Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2295418%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 1,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "California State Board of Pharmacy (DCA License Search)",
   "url": "https://search.dca.ca.gov/",
   "kind": "license lookup"
  },
  "state_name": "California"
 },
 {
  "listed_as": "NLRx, LLC, Cookeville, TN",
  "name": "NLRx, LLC",
  "city": "Cookeville",
  "state": "TN",
  "phone": "1-931-400-8301",
  "initial_registration": "8/7/2026",
  "initial_registration_date": "2026-08-07",
  "recent_registration": "8/7/2026",
  "recent_registration_date": "2026-08-07",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "nlrx-llc-cookeville-tn",
  "aliases": [
   "NLRx, LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Tennessee Department of Health Licensure Verification (Board of Pharmacy)",
   "url": "https://apps.health.tn.gov/Licensure/",
   "kind": "license lookup"
  },
  "state_name": "Tennessee"
 },
 {
  "listed_as": "Nubratori, Inc., Torrance, CA",
  "name": "Nubratori, Inc.",
  "city": "Torrance",
  "state": "CA",
  "phone": "310-218-4153",
  "initial_registration": "2/24/2017",
  "initial_registration_date": "2017-02-24",
  "recent_registration": "12/3/2025",
  "recent_registration_date": "2025-12-03",
  "last_inspection": "12/11/2025",
  "last_inspection_date": "2025-12-11",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/190691/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Warning Letter Closeout Issued 7/27/2026 FMD-145 Letter Issued 7/21/2026",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "nubratori-inc-torrance-ca",
  "aliases": [
   "Nubratori, Inc."
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Nubratori Inc. dba Nubratori Rx, Torrance, CA - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "96699",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nubratori, Inc",
    "firm_city": "Torrance",
    "firm_state": "CA",
    "date": "2025-04-15",
    "report_date": "2025-05-07",
    "classification_date": "2025-04-28",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025."
    ],
    "recall_numbers": [
     "D-0392-2025"
    ],
    "products": [
     "Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI RX, 381 Van Ness Ave"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296699%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "warning_letter_closeout",
    "date": "2026-07-27",
    "match": "table",
    "text": "Warning Letter Closeout Issued 7/27/2026",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "fmd145_letter",
    "date": "2026-07-21",
    "match": "table",
    "text": "FMD-145 Letter Issued 7/21/2026",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "inspection",
    "date": "2025-12-11",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/190691/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-12-11",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/190691/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "recall",
    "event_id": "96699",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Nubratori, Inc",
    "firm_city": "Torrance",
    "firm_state": "CA",
    "date": "2025-04-15",
    "report_date": "2025-05-07",
    "classification_date": "2025-04-28",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto 0.4% are labeled incorrectly with a BUD of 12/25/2025."
    ],
    "recall_numbers": [
     "D-0392-2025"
    ],
    "products": [
     "Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), Rx Only, 12 - 5 mL Single Dose Units per box, Preservative Free, For Iontophoresis Use Only, Non-Sterile Product, Not for Injection, NUBRATORI RX, 381 Van Ness Ave"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296699%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "warning_letter",
    "date": "2025-01-22",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter Issued 01/22/2025",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nubratori-inc-dba-nubratori-rx-700513-01222025",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Nubratori Inc. dba Nubratori Rx, Torrance, CA - 503B Facility"
   },
   {
    "type": "483",
    "date": "2024-07-26",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 07/26/2024 (PDF - 1.25MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/180707/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Nubratori Inc. dba Nubratori Rx, Torrance, CA - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2022-05-06",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 05/06/2022",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Nubratori Inc. dba Nubratori Rx, Torrance, CA - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2021-09-21",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 09/21/2021",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Nubratori Inc. dba Nubratori Rx, Torrance, CA - 503B Facility"
   },
   {
    "type": "483",
    "date": "2019-09-26",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 09/26/2019 (PDF - 637KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/133037/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Nubratori Inc. dba Nubratori Rx, Torrance, CA - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2019-05-15",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 05/15/2019 (PDF - 65KB)",
    "url": "https://www.fda.gov/media/128395/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Nubratori Inc. dba Nubratori Rx, Torrance, CA - 503B Facility"
   }
  ],
  "counts": {
   "form483": 3,
   "warning_letters": 1,
   "recalls": 1,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "California State Board of Pharmacy (DCA License Search)",
   "url": "https://search.dca.ca.gov/",
   "kind": "license lookup"
  },
  "state_name": "California"
 },
 {
  "listed_as": "Ocyon Bio PR, LLC, Aguadilla, PR",
  "name": "Ocyon Bio PR, LLC",
  "city": "Aguadilla",
  "state": "PR",
  "phone": "1-787-612-5681",
  "initial_registration": "4/23/2026",
  "initial_registration_date": "2026-04-23",
  "recent_registration": "4/23/2026",
  "recent_registration_date": "2026-04-23",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "ocyon-bio-pr-llc-aguadilla-pr",
  "aliases": [
   "Ocyon Bio PR, LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Puerto Rico Department of Health (Board of Pharmacy oversight)",
   "url": "https://www.salud.pr.gov/",
   "kind": "health department site"
  },
  "state_name": "Puerto Rico"
 },
 {
  "listed_as": "Olympia Pharmaceuticals, Orlando, FL",
  "name": "Olympia Pharmaceuticals",
  "city": "Orlando",
  "state": "FL",
  "phone": "1-407-673-2222",
  "initial_registration": "3/10/2014",
  "initial_registration_date": "2014-03-10",
  "recent_registration": "11/20/2025",
  "recent_registration_date": "2025-11-20",
  "last_inspection": "9/3/2026",
  "last_inspection_date": "2026-09-03",
  "form483_issued": "Yes",
  "form483_links": [],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "olympia-pharmaceuticals-orlando-fl",
  "aliases": [
   "Olympia Pharmaceuticals"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "OPS International, Inc., (dba Olympia Pharmacy), Orlando, FL - 503B Facility",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-09-03",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-09-03",
    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page (\"483 Issued 09/03/2026 (PDF - 2MB)\"). That listing is an uncertain match: Similar (not identical) name with same city and state",
    "url": "https://www.fda.gov/media/195123/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-08-08",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state",
    "text": "Amended 483 Issued 08/08/2025 (PDF - 928 KB)",
    "url": "https://www.fda.gov/media/188647/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "OPS International, Inc., (dba Olympia Pharmacy), Orlando, FL - 503B Facility"
   },
   {
    "type": "483",
    "date": "2024-05-29",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state",
    "text": "483 Issued 05/29/2024 (PDF - 447KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/180579/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "OPS International, Inc., (dba Olympia Pharmacy), Orlando, FL - 503B Facility"
   },
   {
    "type": "regulatory_meeting",
    "date": "2023-02-22",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state",
    "text": "Regulatory Meeting Held 02/22/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "OPS International, Inc., (dba Olympia Pharmacy), Orlando, FL - 503B Facility"
   },
   {
    "type": "483",
    "date": "2022-03-02",
    "match": "uncertain",
    "match_reason": "Similar (not identical) name with same city and state",
    "text": "483 Issued 03/02/2022 (PDF - 4.08MB)",
    "url": "https://www.fda.gov/media/160667/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "OPS International, Inc., (dba Olympia Pharmacy), Orlando, FL - 503B Facility"
   }
  ],
  "counts": {
   "form483": 1,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 4
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Florida Department of Health License Verification (Board of Pharmacy)",
   "url": "https://mqa-internet.doh.state.fl.us/MQASearchServices/Home",
   "kind": "license lookup"
  },
  "state_name": "Florida"
 },
 {
  "listed_as": "Olyx Pharma, Schertz, TX",
  "name": "Olyx Pharma",
  "city": "Schertz",
  "state": "TX",
  "phone": "1-510-386-4072",
  "initial_registration": "8/3/2026",
  "initial_registration_date": "2026-08-03",
  "recent_registration": "8/3/2026",
  "recent_registration_date": "2026-08-03",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "olyx-pharma-schertz-tx",
  "aliases": [
   "Olyx Pharma"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Texas State Board of Pharmacy License Verification",
   "url": "https://www.pharmacy.texas.gov/dbsearch/phy_search.asp",
   "kind": "license lookup"
  },
  "state_name": "Texas"
 },
 {
  "listed_as": "Orion Specialty Labs, LLC",
  "name": "Orion Specialty Labs, LLC",
  "city": null,
  "state": null,
  "phone": "1-917-414-2469",
  "initial_registration": "9/19/2025",
  "initial_registration_date": "2025-09-19",
  "recent_registration": "2/24/2026",
  "recent_registration_date": "2026-02-24",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "orion-specialty-labs-llc",
  "aliases": [
   "Orion Specialty Labs, LLC"
  ],
  "data_notes": [
   "FDA's table does not list a city/state for this facility."
  ],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "State boards of pharmacy (NABP directory)",
   "url": "https://nabp.pharmacy/about/boards-of-pharmacy/",
   "kind": "directory"
  }
 },
 {
  "listed_as": "OSRX, Inc., Missoula, MT",
  "name": "OSRX, Inc.",
  "city": "Missoula",
  "state": "MT",
  "phone": "406-541-6121",
  "initial_registration": "10/28/2023",
  "initial_registration_date": "2023-10-28",
  "recent_registration": "12/29/2025",
  "recent_registration_date": "2025-12-29",
  "last_inspection": "11/14/2025",
  "last_inspection_date": "2025-11-14",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/190602/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "osrx-inc-missoula-mt",
  "aliases": [
   "OSRX, Inc."
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "OSRX, Inc., Missoula, MT - 503A Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   },
   {
    "heading": "OSRX, Inc., Missoula, MT - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "inspection",
    "date": "2025-11-14",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/190602/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-11-14",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/190602/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "warning_letter",
    "date": "2025-04-23",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter Issued 04/23/2025",
    "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/osrx-inc-701889-04232025",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "OSRX, Inc., Missoula, MT - 503B Facility"
   },
   {
    "type": "483",
    "date": "2024-10-25",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 10/25/2024 (PDF - 1.45MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/183626/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "OSRX, Inc., Missoula, MT - 503B Facility"
   },
   {
    "type": "483",
    "date": "2021-09-23",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 09/23/2021 (PDF - 386KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/156389/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "OSRX, Inc., Missoula, MT - 503A Facility"
   },
   {
    "type": "untitled_letter",
    "date": "2020-10-05",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Untitled Letter Issued 10/05/2020 (PDF - 166KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/180709/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "OSRX, Inc., Missoula, MT - 503A Facility"
   }
  ],
  "counts": {
   "form483": 3,
   "warning_letters": 1,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Montana Professional Licensing Search (Board of Pharmacy)",
   "url": "https://ebizws.mt.gov/PUBLICPORTAL/searchform?mylist=licenses",
   "kind": "license lookup"
  },
  "state_name": "Montana"
 },
 {
  "listed_as": "OurPharma LLC, Fayetteville, AR",
  "name": "OurPharma LLC",
  "city": "Fayetteville",
  "state": "AR",
  "phone": "479-313-8200 Ext 8227",
  "initial_registration": "3/15/2019",
  "initial_registration_date": "2019-03-15",
  "recent_registration": "11/26/2025",
  "recent_registration_date": "2025-11-26",
  "last_inspection": "8/12/2026",
  "last_inspection_date": "2026-08-12",
  "form483_issued": "Yes",
  "form483_links": [],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "ourpharma-llc-fayetteville-ar",
  "aliases": [
   "OurPharma LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "OurPharma LLC, Fayetteville, AR - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "99837",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "OurPharma LLC",
    "firm_city": "Fayetteville",
    "firm_state": "AR",
    "date": "2026-09-03",
    "report_date": "2026-09-16",
    "classification_date": "2026-09-21",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026)."
    ],
    "recall_numbers": [
     "D-0864-2026"
    ],
    "products": [
     "fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2299837%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "96706",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "OurPharma LLC",
    "firm_city": "Fayetteville",
    "firm_state": "AR",
    "date": "2025-04-15",
    "report_date": "2025-04-30",
    "classification_date": "2025-04-21",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification.."
    ],
    "recall_numbers": [
     "D-0385-2025"
    ],
    "products": [
     "HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701,  NDC 73013-1040-01."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296706%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "91520",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "OurPharma LLC",
    "firm_city": "Fayetteville",
    "firm_state": "AR",
    "date": "2023-01-13",
    "report_date": "2023-02-01",
    "classification_date": "2023-01-23",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Short Fill: Underfilled units."
    ],
    "recall_numbers": [
     "D-0172-2023"
    ],
    "products": [
     "FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1001-01."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291520%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "91229",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "OurPharma LLC",
    "firm_city": "Fayetteville",
    "firm_state": "AR",
    "date": "2022-11-29",
    "report_date": "2022-12-21",
    "classification_date": "2022-12-09",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Underfilled units."
    ],
    "recall_numbers": [
     "D-0078-2023"
    ],
    "products": [
     "FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291229%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "recall",
    "event_id": "99837",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "OurPharma LLC",
    "firm_city": "Fayetteville",
    "firm_state": "AR",
    "date": "2026-09-03",
    "report_date": "2026-09-16",
    "classification_date": "2026-09-21",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026)."
    ],
    "recall_numbers": [
     "D-0864-2026"
    ],
    "products": [
     "fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2299837%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "inspection",
    "date": "2026-08-12",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-08-12",
    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page (\"483 Issued 08/12/2026 (PDF - 1.64MB)\")",
    "url": "https://www.fda.gov/media/194848/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "fmd145_letter",
    "date": "2025-06-23",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 06/23/2025",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "OurPharma LLC, Fayetteville, AR - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "96706",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "OurPharma LLC",
    "firm_city": "Fayetteville",
    "firm_state": "AR",
    "date": "2025-04-15",
    "report_date": "2025-04-30",
    "classification_date": "2025-04-21",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification.."
    ],
    "recall_numbers": [
     "D-0385-2025"
    ],
    "products": [
     "HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL), packaged in a 50 mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701,  NDC 73013-1040-01."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296706%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2024-09-27",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 09/27/2024 (PDF - 1.02MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/185237/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "OurPharma LLC, Fayetteville, AR - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "91520",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "OurPharma LLC",
    "firm_city": "Fayetteville",
    "firm_state": "AR",
    "date": "2023-01-13",
    "report_date": "2023-02-01",
    "classification_date": "2023-01-23",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Short Fill: Underfilled units."
    ],
    "recall_numbers": [
     "D-0172-2023"
    ],
    "products": [
     "FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1001-01."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291520%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "91229",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "OurPharma LLC",
    "firm_city": "Fayetteville",
    "firm_state": "AR",
    "date": "2022-11-29",
    "report_date": "2022-12-21",
    "classification_date": "2022-12-09",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Underfilled units."
    ],
    "recall_numbers": [
     "D-0078-2023"
    ],
    "products": [
     "FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291229%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "fmd145_letter",
    "date": "2022-03-14",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 03/14/2022",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "OurPharma LLC, Fayetteville, AR - 503B Facility"
   },
   {
    "type": "483",
    "date": "2021-09-30",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 09/30/2021 (PDF - 445KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/154264/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "OurPharma LLC, Fayetteville, AR - 503B Facility"
   }
  ],
  "counts": {
   "form483": 3,
   "warning_letters": 0,
   "recalls": 4,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Arkansas State Board of Pharmacy",
   "url": "https://www.pharmacyboard.arkansas.gov/",
   "kind": "board site"
  },
  "state_name": "Arkansas"
 },
 {
  "listed_as": "Park Avenue Compounding, St. Louis, MO",
  "name": "Park Avenue Compounding",
  "city": "St. Louis",
  "state": "MO",
  "phone": "603-953-6675",
  "initial_registration": "12/23/2023",
  "initial_registration_date": "2023-12-23",
  "recent_registration": "11/19/2025",
  "recent_registration_date": "2025-11-19",
  "last_inspection": "9/23/2025",
  "last_inspection_date": "2025-09-23",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/190198/download?attachment"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Regulatory Meeting Held 5/7/2026",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "No",
  "slug": "park-avenue-compounding-st-louis-mo",
  "aliases": [
   "Park Avenue Compounding"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [
   {
    "type": "recall",
    "event_id": "97938",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Park Avenue Compounding",
    "firm_city": "Saint Louis",
    "firm_state": "MO",
    "date": "2025-09-23",
    "report_date": "2025-11-26",
    "classification_date": "2025-11-20",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results."
    ],
    "recall_numbers": [
     "D-0178-2026"
    ],
    "products": [
     "Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII,  150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297938%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "97960",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Park Avenue Compounding",
    "firm_city": "Saint Louis",
    "firm_state": "MO",
    "date": "2025-09-17",
    "report_date": "2025-12-10",
    "classification_date": "2025-12-02",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "CGMP Deviations"
    ],
    "recall_numbers": [
     "D-0200-2026"
    ],
    "products": [
     "Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297960%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "regulatory_meeting",
    "date": "2026-05-07",
    "match": "table",
    "text": "Regulatory Meeting Held 5/7/2026",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "inspection",
    "date": "2025-09-23",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/190198/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-09-23",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/190198/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "recall",
    "event_id": "97938",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Park Avenue Compounding",
    "firm_city": "Saint Louis",
    "firm_state": "MO",
    "date": "2025-09-23",
    "report_date": "2025-11-26",
    "classification_date": "2025-11-20",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results."
    ],
    "recall_numbers": [
     "D-0178-2026"
    ],
    "products": [
     "Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII,  150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297938%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "97960",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Park Avenue Compounding",
    "firm_city": "Saint Louis",
    "firm_state": "MO",
    "date": "2025-09-17",
    "report_date": "2025-12-10",
    "classification_date": "2025-12-02",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "CGMP Deviations"
    ],
    "recall_numbers": [
     "D-0200-2026"
    ],
    "products": [
     "Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 83863-0104-1."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297960%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "counts": {
   "form483": 1,
   "warning_letters": 0,
   "recalls": 2,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Missouri Division of Professional Registration Licensee Search (Board of Pharmacy)",
   "url": "https://pr.mo.gov/licensee-search.asp",
   "kind": "license lookup"
  },
  "state_name": "Missouri"
 },
 {
  "listed_as": "PGRrx LLC, Exton, PA",
  "name": "PGRrx LLC",
  "city": "Exton",
  "state": "PA",
  "phone": "1-484-883-7597",
  "initial_registration": "12/10/2024",
  "initial_registration_date": "2024-12-10",
  "recent_registration": "12/30/2025",
  "recent_registration_date": "2025-12-30",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "pgrrx-llc-exton-pa",
  "aliases": [
   "PGRrx LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Pennsylvania Licensing System (PALS) Verification (State Board of Pharmacy)",
   "url": "https://www.pals.pa.gov/",
   "kind": "license lookup"
  },
  "state_name": "Pennsylvania"
 },
 {
  "listed_as": "Pine Pharmaceuticals, LLC, Tonawanda, NY",
  "name": "Pine Pharmaceuticals, LLC",
  "city": "Tonawanda",
  "state": "NY",
  "phone": "716-248-1025",
  "initial_registration": "3/9/2018",
  "initial_registration_date": "2018-03-09",
  "recent_registration": "10/9/2026",
  "recent_registration_date": "2026-10-09",
  "last_inspection": "11/14/2025",
  "last_inspection_date": "2025-11-14",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/190690/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Warning Letter Issued 8/7/2026",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "pine-pharmaceuticals-llc-tonawanda-ny",
  "aliases": [
   "Pine Pharmaceuticals, LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Pine Pharmaceuticals, Tonawanda, NY - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "93154",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Pine Pharmaceuticals, LLC",
    "firm_city": "Tonawanda",
    "firm_state": "NY",
    "date": "2023-10-02",
    "report_date": "2023-10-25",
    "classification_date": "2023-10-19",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0050-2024",
     "D-0051-2024",
     "D-0052-2024",
     "D-0053-2024",
     "D-0054-2024",
     "D-0055-2024",
     "D-0056-2024",
     "D-0057-2024",
     "D-0058-2024",
     "D-0059-2024",
     "D-0060-2024",
     "D-0061-2024",
     "D-0062-2024",
     "D-0063-2024",
     "D-0064-2024",
     "D-0065-2024"
    ],
    "products": [
     "Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.",
     "Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.",
     "Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.",
     "Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.",
     "Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293154%22&limit=100",
    "classification": "Class II",
    "product_count": 16,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "91972",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Pine Pharmaceuticals, LLC",
    "firm_city": "Tonawanda",
    "firm_state": "NY",
    "date": "2023-03-27",
    "report_date": "2023-04-19",
    "classification_date": "2023-04-13",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect."
    ],
    "recall_numbers": [
     "D-0531-2023"
    ],
    "products": [
     "Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in individually labeled poly envelopes (primary packaging).  Repackaged by Pine Pharmaceuticals, Pine Pharmaceuticals 355 Riverw"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291972%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "91378",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Pine Pharmaceuticals, LLC",
    "firm_city": "Tonawanda",
    "firm_state": "NY",
    "date": "2022-12-22",
    "report_date": "2023-01-11",
    "classification_date": "2023-01-13",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "CGMP Deviations: Raw material recalled by repackager, due to discoloration."
    ],
    "recall_numbers": [
     "D-0130-2023"
    ],
    "products": [
     "Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded by Pine Pharmaceuticals, 355 Riverwalk Pkwy, Tonawanda, NY 14150. NDC 69194-0948-1"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291378%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "90854",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Pine Pharmaceuticals, LLC",
    "firm_city": "Tonawanda",
    "firm_state": "NY",
    "date": "2022-07-27",
    "report_date": "2022-09-21",
    "classification_date": "2022-09-15",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-1514-2022"
    ],
    "products": [
     "Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 mL prefilled syringe, Item# 803, barcode 6919408031; b) 5 mL prefilled syringe, Item# 933, barcode 6919409331, Rx only, "
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2290854%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "79457",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Pine Pharmaceuticals, LLC",
    "firm_city": "Tonawanda",
    "firm_state": "NY",
    "date": "2018-03-05",
    "report_date": "2018-03-28",
    "classification_date": "2018-03-26",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product."
    ],
    "recall_numbers": [
     "D-0607-2018"
    ],
    "products": [
     "Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL  Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy Tonawanda, NY 14150. NDC 69194-0358-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2279457%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "72629",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Pine Pharmaceuticals, LLC",
    "firm_city": "Tonawanda",
    "firm_state": "NY",
    "date": "2015-11-04",
    "report_date": "2016-01-27",
    "classification_date": "2016-01-20",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use."
    ],
    "recall_numbers": [
     "D-0581-2016",
     "D-0582-2016",
     "D-0583-2016",
     "D-0584-2016"
    ],
    "products": [
     "Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16\" Syringe for intravitreal Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.",
     "Bevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16\" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.",
     "Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16\" Syringe for intravitreal injection, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.",
     "Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16\" Syringe for intravitreal, Rx --  Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2272629%22&limit=100",
    "classification": "Class II",
    "product_count": 4,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "warning_letter",
    "date": "2026-08-07",
    "match": "table",
    "text": "Warning Letter Issued 8/7/2026",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "inspection",
    "date": "2025-11-14",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/190690/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-11-14",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/190690/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2024-09-30",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 09/30/2024 (PDF - 18.6 MB)",
    "url": "https://www.fda.gov/media/185430/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Pine Pharmaceuticals, Tonawanda, NY - 503B Facility"
   },
   {
    "type": "regulatory_meeting",
    "date": "2024-03-14",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Regulatory Meeting Held 03/14/2024",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Pine Pharmaceuticals, Tonawanda, NY - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "93154",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Pine Pharmaceuticals, LLC",
    "firm_city": "Tonawanda",
    "firm_state": "NY",
    "date": "2023-10-02",
    "report_date": "2023-10-25",
    "classification_date": "2023-10-19",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0050-2024",
     "D-0051-2024",
     "D-0052-2024",
     "D-0053-2024",
     "D-0054-2024",
     "D-0055-2024",
     "D-0056-2024",
     "D-0057-2024",
     "D-0058-2024",
     "D-0059-2024",
     "D-0060-2024",
     "D-0061-2024",
     "D-0062-2024",
     "D-0063-2024",
     "D-0064-2024",
     "D-0065-2024"
    ],
    "products": [
     "Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.",
     "Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.",
     "Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.",
     "Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.",
     "Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293154%22&limit=100",
    "classification": "Class II",
    "product_count": 16,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2023-09-19",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 9/19/2023 (PDF - 1 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/173117/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Pine Pharmaceuticals, Tonawanda, NY - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "91972",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Pine Pharmaceuticals, LLC",
    "firm_city": "Tonawanda",
    "firm_state": "NY",
    "date": "2023-03-27",
    "report_date": "2023-04-19",
    "classification_date": "2023-04-13",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect."
    ],
    "recall_numbers": [
     "D-0531-2023"
    ],
    "products": [
     "Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in individually labeled poly envelopes (primary packaging).  Repackaged by Pine Pharmaceuticals, Pine Pharmaceuticals 355 Riverw"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291972%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "91378",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Pine Pharmaceuticals, LLC",
    "firm_city": "Tonawanda",
    "firm_state": "NY",
    "date": "2022-12-22",
    "report_date": "2023-01-11",
    "classification_date": "2023-01-13",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "CGMP Deviations: Raw material recalled by repackager, due to discoloration."
    ],
    "recall_numbers": [
     "D-0130-2023"
    ],
    "products": [
     "Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded by Pine Pharmaceuticals, 355 Riverwalk Pkwy, Tonawanda, NY 14150. NDC 69194-0948-1"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291378%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "90854",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Pine Pharmaceuticals, LLC",
    "firm_city": "Tonawanda",
    "firm_state": "NY",
    "date": "2022-07-27",
    "report_date": "2022-09-21",
    "classification_date": "2022-09-15",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-1514-2022"
    ],
    "products": [
     "Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 mL prefilled syringe, Item# 803, barcode 6919408031; b) 5 mL prefilled syringe, Item# 933, barcode 6919409331, Rx only, "
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2290854%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2021-05-14",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 05/14/2021 (PDF - 1 MB)",
    "url": "https://www.fda.gov/media/152333/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Pine Pharmaceuticals, Tonawanda, NY - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "79457",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Pine Pharmaceuticals, LLC",
    "firm_city": "Tonawanda",
    "firm_state": "NY",
    "date": "2018-03-05",
    "report_date": "2018-03-28",
    "classification_date": "2018-03-26",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product."
    ],
    "recall_numbers": [
     "D-0607-2018"
    ],
    "products": [
     "Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL  Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy Tonawanda, NY 14150. NDC 69194-0358-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2279457%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "72629",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Pine Pharmaceuticals, LLC",
    "firm_city": "Tonawanda",
    "firm_state": "NY",
    "date": "2015-11-04",
    "report_date": "2016-01-27",
    "classification_date": "2016-01-20",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use."
    ],
    "recall_numbers": [
     "D-0581-2016",
     "D-0582-2016",
     "D-0583-2016",
     "D-0584-2016"
    ],
    "products": [
     "Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16\" Syringe for intravitreal Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.",
     "Bevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16\" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.",
     "Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16\" Syringe for intravitreal injection, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.",
     "Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16\" Syringe for intravitreal, Rx --  Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2272629%22&limit=100",
    "classification": "Class II",
    "product_count": 4,
    "source": "openFDA drug enforcement API"
   }
  ],
  "counts": {
   "form483": 4,
   "warning_letters": 1,
   "recalls": 6,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "NYSED Office of the Professions Verification Search (Pharmacy)",
   "url": "https://eservices.nysed.gov/professions/verification-search",
   "kind": "license lookup"
  },
  "state_name": "New York"
 },
 {
  "listed_as": "PQ Pharmacy LLC, Brooksville, FL",
  "name": "PQ Pharmacy LLC",
  "city": "Brooksville",
  "state": "FL",
  "phone": "352-477-8977",
  "initial_registration": "10/29/2020",
  "initial_registration_date": "2020-10-29",
  "recent_registration": "12/11/2025",
  "recent_registration_date": "2025-12-11",
  "last_inspection": "6/1/2026",
  "last_inspection_date": "2026-06-01",
  "form483_issued": "Yes",
  "form483_links": [],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "pq-pharmacy-llc-brooksville-fl",
  "aliases": [
   "PQ Pharmacy LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "PQ Pharmacy, LLC, Brooksville, FL - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-06-01",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-06-01",
    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page (\"483 Issued 06/01/2026 (PDF - 14 MB)\")",
    "url": "https://www.fda.gov/media/194819/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "warning_letter",
    "date": "2025-10-10",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter (10/10/2025)",
    "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pq-pharmacy-llc-715795-10102025",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "PQ Pharmacy, LLC, Brooksville, FL - 503B Facility"
   },
   {
    "type": "483",
    "date": "2025-04-04",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 issued 04/04/2025 (PDF - 1.82 MB)",
    "url": "https://www.fda.gov/media/186269/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "PQ Pharmacy, LLC, Brooksville, FL - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2023-03-30",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 3/30/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "PQ Pharmacy, LLC, Brooksville, FL - 503B Facility"
   },
   {
    "type": "483",
    "date": "2022-11-17",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Amended 483 Issued 11/17/2022 (PDF - 1.4 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/169650/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "PQ Pharmacy, LLC, Brooksville, FL - 503B Facility"
   },
   {
    "type": "483",
    "date": "2022-10-27",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 10/27/2022 (PDF - 1.39 MB)",
    "url": "https://www.fda.gov/media/164727/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "PQ Pharmacy, LLC, Brooksville, FL - 503B Facility"
   }
  ],
  "counts": {
   "form483": 4,
   "warning_letters": 1,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Florida Department of Health License Verification (Board of Pharmacy)",
   "url": "https://mqa-internet.doh.state.fl.us/MQASearchServices/Home",
   "kind": "license lookup"
  },
  "state_name": "Florida"
 },
 {
  "listed_as": "ProRx LLC, Exton, PA",
  "name": "ProRx LLC",
  "city": "Exton",
  "state": "PA",
  "phone": "1-904-616-7355",
  "initial_registration": "4/27/2022",
  "initial_registration_date": "2022-04-27",
  "recent_registration": "2/20/2026",
  "recent_registration_date": "2026-02-20",
  "last_inspection": "9/19/2025",
  "last_inspection_date": "2025-09-19",
  "form483_issued": "Yes",
  "form483_links": [],
  "recall_conducted": "No",
  "action_last_inspection": "Warning Letter Issued 4/7/2026",
  "action_links": [
   {
    "text": "Warning Letter Issued 4/7/2026",
    "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026"
   }
  ],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "prorx-llc-exton-pa",
  "aliases": [
   "ProRx LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "ProRX LLC, Exton, PA - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "97808",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "ProRx LLC",
    "firm_city": "Exton",
    "firm_state": "PA",
    "date": "2025-10-15",
    "report_date": "2025-11-05",
    "classification_date": "2025-10-27",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0114-2026",
     "D-0115-2026",
     "D-0116-2026",
     "D-0117-2026",
     "D-0118-2026",
     "D-0119-2026",
     "D-0120-2026"
    ],
    "products": [
     "Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341.  NDC:  84139-225-04",
     "Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341.  NDC:  84139-225-08",
     "Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341.  NDC:  84139-225-06",
     "Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341.  NDC:  84139-225-09",
     "Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341.  NDC:  84139-209-03"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297808%22&limit=100",
    "classification": "Class II",
    "product_count": 7,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "95190",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "ProRx LLC",
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    "report_date": "2024-09-11",
    "classification_date": "2024-09-05",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
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    ],
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     "D-0651-2024",
     "D-0652-2024",
     "D-0653-2024",
     "D-0654-2024",
     "D-0655-2024",
     "D-0656-2024"
    ],
    "products": [
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     "Semaglutide / Cyanocobalamin Injection:  2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02",
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     "TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only,  3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2295190%22&limit=100",
    "classification": "Class II",
    "product_count": 7,
    "source": "openFDA drug enforcement API"
   }
  ],
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   {
    "type": "warning_letter",
    "date": "2026-04-07",
    "match": "table",
    "text": "Warning Letter Issued 4/7/2026",
    "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-723704-04072026",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "recall",
    "event_id": "97808",
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    "match_reason": "Exact name, city and state match",
    "recalling_firm": "ProRx LLC",
    "firm_city": "Exton",
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    "report_date": "2025-11-05",
    "classification_date": "2025-10-27",
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    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
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     "D-0115-2026",
     "D-0116-2026",
     "D-0117-2026",
     "D-0118-2026",
     "D-0119-2026",
     "D-0120-2026"
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    "products": [
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     "Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341.  NDC:  84139-225-09",
     "Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341.  NDC:  84139-209-03"
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    "classification": "Class II",
    "product_count": 7,
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    "type": "inspection",
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    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
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    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page (\"483 Issued 09/19/2025\")",
    "url": "https://www.fda.gov/media/190142/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "warning_letter",
    "date": "2025-03-04",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Amended Warning Letter Issued 03/04/2025",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prorx-llc-696742-03042025",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "ProRX LLC, Exton, PA - 503B Facility"
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    "event_id": "95190",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
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    "firm_city": "Exton",
    "firm_state": "PA",
    "date": "2024-08-22",
    "report_date": "2024-09-11",
    "classification_date": "2024-09-05",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
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     "D-0650-2024",
     "D-0651-2024",
     "D-0652-2024",
     "D-0653-2024",
     "D-0654-2024",
     "D-0655-2024",
     "D-0656-2024"
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    "products": [
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   },
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    "match_reason": "Exact name, city and state match",
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    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/182243/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "ProRX LLC, Exton, PA - 503B Facility"
   }
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  "counts": {
   "form483": 2,
   "warning_letters": 2,
   "recalls": 2,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Pennsylvania Licensing System (PALS) Verification (State Board of Pharmacy)",
   "url": "https://www.pals.pa.gov/",
   "kind": "license lookup"
  },
  "state_name": "Pennsylvania"
 },
 {
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  "city": "Edmond",
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  "initial_registration_date": "2015-05-23",
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  "recent_registration_date": "2025-12-17",
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    "heading": "Qualgen LLC, Edmond, OK - 503B Facility",
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    "match_reason": "Exact name, city and state match"
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    "recalling_firm": "Qualgen, LLC",
    "firm_city": "Edmond",
    "firm_state": "OK",
    "date": "2025-06-16",
    "report_date": "2025-07-23",
    "classification_date": "2025-07-14",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label."
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    "recall_numbers": [
     "D-0517-2025"
    ],
    "products": [
     "Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297086%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
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    "type": "recall",
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    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Qualgen, LLC",
    "firm_city": "Edmond",
    "firm_state": "OK",
    "date": "2018-10-17",
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    "classification_date": "2018-11-07",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
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     "D-0226-2019",
     "D-0227-2019",
     "D-0228-2019",
     "D-0229-2019",
     "D-0230-2019",
     "D-0231-2019",
     "D-0232-2019",
     "D-0233-2019",
     "D-0234-2019",
     "D-0235-2019",
     "D-0236-2019",
     "D-0237-2019",
     "D-0238-2019"
    ],
    "products": [
     "Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013",
     "Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 count (NDC 69761-150-12), and 30 count (NDC 69761-150-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013",
     "Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013",
     "Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013",
     "Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-110-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2281346%22&limit=100",
    "classification": "Class II",
    "product_count": 14,
    "source": "openFDA drug enforcement API"
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    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2280203%22&limit=100",
    "classification": "Class III",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
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    "type": "recall",
    "event_id": "77064",
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    "match_reason": "Exact name, city and state match",
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    "classification_date": "2017-06-07",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
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     "D-0890-2017",
     "D-0891-2017",
     "D-0892-2017",
     "D-0893-2017",
     "D-0894-2017",
     "D-0895-2017",
     "D-0896-2017"
    ],
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     "Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, ND",
     "Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only , For Subcutaneous Use Only Rx Only Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 6",
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     "Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid  NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 6"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2277064%22&limit=100",
    "classification": "Class II",
    "product_count": 8,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "72401",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Qualgen",
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    "firm_state": "OK",
    "date": "2015-10-09",
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    "classification_date": "2015-11-24",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
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    "recall_numbers": [
     "D-0386-2016",
     "D-0387-2016"
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    "products": [
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     "Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC 69761-125-01), 37.5 mg (NDC 69761-137-01), 50 mg (NDC 69761-150-01), 87.5 mg (NDC: 69761-187-01), 100 mg (NDC 69761-110-01), 200 mg (NDC 69761-120-01), R"
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    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2272401%22&limit=100",
    "classification": "Class II",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
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  ],
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    "type": "inspection",
    "date": "2025-09-04",
    "match": "table",
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    "url": null,
    "source": "FDA registered outsourcing facilities table"
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    "url": "https://www.fda.gov/media/190601/download",
    "source": "FDA registered outsourcing facilities table"
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    "type": "recall",
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    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Qualgen, LLC",
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    "firm_state": "OK",
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     "Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label."
    ],
    "recall_numbers": [
     "D-0517-2025"
    ],
    "products": [
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    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297086%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2024-03-19",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 03/19/2024 (PDF - 3MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/182460/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Qualgen LLC, Edmond, OK - 503B Facility"
   },
   {
    "type": "court_action",
    "date": "2022-12-19",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FDA Press Release: Federal Court Enters Consent Decree Against Oklahoma Drug Compounder (12/19/2022)",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Qualgen LLC, Edmond, OK - 503B Facility"
   },
   {
    "type": "483",
    "date": "2022-09-30",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 09/30/2022 (PDF - 1.69MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/163431/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Qualgen LLC, Edmond, OK - 503B Facility"
   },
   {
    "type": "483",
    "date": "2021-06-15",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 06/15/2021 (PDF - 2.5MB)",
    "url": "https://www.fda.gov/media/158160/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Qualgen LLC, Edmond, OK - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "81346",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Qualgen, LLC",
    "firm_city": "Edmond",
    "firm_state": "OK",
    "date": "2018-10-17",
    "report_date": "2018-11-14",
    "classification_date": "2018-11-07",
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    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
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    "recall_numbers": [
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     "D-0228-2019",
     "D-0229-2019",
     "D-0230-2019",
     "D-0231-2019",
     "D-0232-2019",
     "D-0233-2019",
     "D-0234-2019",
     "D-0235-2019",
     "D-0236-2019",
     "D-0237-2019",
     "D-0238-2019"
    ],
    "products": [
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     "Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013",
     "Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013",
     "Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-110-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2281346%22&limit=100",
    "classification": "Class II",
    "product_count": 14,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "80203",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Qualgen, LLC",
    "firm_city": "Edmond",
    "firm_state": "OK",
    "date": "2018-06-08",
    "report_date": "2018-07-11",
    "classification_date": "2018-06-29",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Incorrect or Missing Lot and/or Exp Date."
    ],
    "recall_numbers": [
     "D-0892-2018",
     "D-0893-2018"
    ],
    "products": [
     "ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01",
     "TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2280203%22&limit=100",
    "classification": "Class III",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "77064",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Qualgen",
    "firm_city": "Edmond",
    "firm_state": "OK",
    "date": "2017-04-19",
    "report_date": "2017-06-14",
    "classification_date": "2017-06-07",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "CGMP deviations- Lack of Quality Assurance"
    ],
    "recall_numbers": [
     "D-0889-2017",
     "D-0890-2017",
     "D-0891-2017",
     "D-0892-2017",
     "D-0893-2017",
     "D-0894-2017",
     "D-0895-2017",
     "D-0896-2017"
    ],
    "products": [
     "Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01",
     "Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, ND",
     "Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only , For Subcutaneous Use Only Rx Only Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 6",
     "Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 6",
     "Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid  NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 6"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2277064%22&limit=100",
    "classification": "Class II",
    "product_count": 8,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "72401",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Qualgen",
    "firm_city": "Edmond",
    "firm_state": "OK",
    "date": "2015-10-09",
    "report_date": "2015-12-02",
    "classification_date": "2015-11-24",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance."
    ],
    "recall_numbers": [
     "D-0386-2016",
     "D-0387-2016"
    ],
    "products": [
     "Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC 69761-010-01),12.5 mg (NDC 69761-012-01), 15 mg (NDC 69761-015-01),18 mg (NDC 69761-018-01),20 mg (NDC 69761-020-01), 22 mg (NDC 697",
     "Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC 69761-125-01), 37.5 mg (NDC 69761-137-01), 50 mg (NDC 69761-150-01), 87.5 mg (NDC: 69761-187-01), 100 mg (NDC 69761-110-01), 200 mg (NDC 69761-120-01), R"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2272401%22&limit=100",
    "classification": "Class II",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   }
  ],
  "counts": {
   "form483": 4,
   "warning_letters": 0,
   "recalls": 5,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Oklahoma State Board of Pharmacy",
   "url": "https://www.pharmacy.ok.gov/",
   "kind": "board site"
  },
  "state_name": "Oklahoma"
 },
 {
  "listed_as": "Quantum Pharmaceuticals, LLC, Mounds, OK",
  "name": "Quantum Pharmaceuticals, LLC",
  "city": "Mounds",
  "state": "OK",
  "phone": "479-263-2690",
  "initial_registration": "5/30/2024",
  "initial_registration_date": "2024-05-30",
  "recent_registration": "11/26/2025",
  "recent_registration_date": "2025-11-26",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "quantum-pharmaceuticals-llc-mounds-ok",
  "aliases": [
   "Quantum Pharmaceuticals, LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Oklahoma State Board of Pharmacy",
   "url": "https://www.pharmacy.ok.gov/",
   "kind": "board site"
  },
  "state_name": "Oklahoma"
 },
 {
  "listed_as": "Quva Pharma, Inc., Bloomsbury, NJ",
  "name": "Quva Pharma, Inc.",
  "city": "Bloomsbury",
  "state": "NJ",
  "phone": "1-908-388-1079",
  "initial_registration": "9/15/2017",
  "initial_registration_date": "2017-09-15",
  "recent_registration": "12/4/2025",
  "recent_registration_date": "2025-12-04",
  "last_inspection": "4/4/2025",
  "last_inspection_date": "2025-04-04",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/186263/download?attachment"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "quva-pharma-inc-bloomsbury-nj",
  "aliases": [
   "Quva Pharma, Inc."
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "QuVa Pharma, Inc., Bloomsbury, NJ - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "90898",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "QuVa Pharma, Inc.",
    "firm_city": "Bloomsbury",
    "firm_state": "NJ",
    "date": "2022-09-20",
    "report_date": "2022-10-05",
    "classification_date": "2022-09-26",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL)."
    ],
    "recall_numbers": [
     "D-1544-2022"
    ],
    "products": [
     "oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, To"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2290898%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "inspection",
    "date": "2025-04-04",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/186263/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-04-04",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/186263/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "warning_letter",
    "date": "2024-01-26",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter Issued 01/26/2024",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/quva-pharma-inc-675685-01262024",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "QuVa Pharma, Inc., Bloomsbury, NJ - 503B Facility"
   },
   {
    "type": "483",
    "date": "2022-10-14",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 10/14/2022 (PDF - 2.54MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/163673/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "QuVa Pharma, Inc., Bloomsbury, NJ - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "90898",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "QuVa Pharma, Inc.",
    "firm_city": "Bloomsbury",
    "firm_state": "NJ",
    "date": "2022-09-20",
    "report_date": "2022-10-05",
    "classification_date": "2022-09-26",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL)."
    ],
    "recall_numbers": [
     "D-1544-2022"
    ],
    "products": [
     "oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, To"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2290898%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2019-05-31",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 05/31/2019 (PDF - 1.69MB)",
    "url": "https://www.fda.gov/media/128373/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "QuVa Pharma, Inc., Bloomsbury, NJ - 503B Facility"
   }
  ],
  "counts": {
   "form483": 3,
   "warning_letters": 1,
   "recalls": 1,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "New Jersey Board of Pharmacy License Verification",
   "url": "https://newjersey.mylicense.com/verification/",
   "kind": "license lookup"
  },
  "state_name": "New Jersey"
 },
 {
  "listed_as": "Quva Pharma, Inc., Sugar Land, TX",
  "name": "Quva Pharma, Inc.",
  "city": "Sugar Land",
  "state": "TX",
  "phone": "1-832-500-7450",
  "initial_registration": "9/10/2015",
  "initial_registration_date": "2015-09-10",
  "recent_registration": "12/2/2025",
  "recent_registration_date": "2025-12-02",
  "last_inspection": "5/4/2026",
  "last_inspection_date": "2026-05-04",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/193419/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "quva-pharma-inc-sugar-land-tx",
  "aliases": [
   "Quva Pharma, Inc."
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "QuVa Pharma, Inc. Sugar Land, TX - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "99311",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "QuVa Pharma, Inc.",
    "firm_city": "Sugar Land",
    "firm_state": "TX",
    "date": "2026-06-24",
    "report_date": "2026-07-15",
    "classification_date": "2026-07-07",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Failed Impurities/Degradation Specifications"
    ],
    "recall_numbers": [
     "D-0664-2026"
    ],
    "products": [
     "Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2299311%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "97790",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "QuVa Pharma, Inc.",
    "firm_city": "Sugar Land",
    "firm_state": "TX",
    "date": "2025-10-10",
    "report_date": "2025-11-05",
    "classification_date": "2025-10-27",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Particulate Matter"
    ],
    "recall_numbers": [
     "D-0113-2026"
    ],
    "products": [
     "R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use.  THIS IS A COMPOUNDED DRUG.  QuVA Pharma, 1075 Wes"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297790%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "96446",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "QuVa Pharma, Inc.",
    "firm_city": "Sugar Land",
    "firm_state": "TX",
    "date": "2025-03-06",
    "report_date": "2025-04-02",
    "classification_date": "2025-03-25",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0295-2025",
     "D-0296-2025",
     "D-0297-2025"
    ],
    "products": [
     "fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Ph",
     "fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma,",
     "fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma,"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296446%22&limit=100",
    "classification": "Class II",
    "product_count": 3,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "85773",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "QuVa Pharma, Inc.",
    "firm_city": "Sugar Land",
    "firm_state": "TX",
    "date": "2020-05-28",
    "report_date": "2020-06-17",
    "classification_date": "2020-06-11",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent drug - Product did not contain drug."
    ],
    "recall_numbers": [
     "D-1302-2020"
    ],
    "products": [
     "oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 888-339-0874, NDC 70092-1068-07"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2285773%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "85547",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "QuVa Pharma, Inc.",
    "firm_city": "Sugar Land",
    "firm_state": "TX",
    "date": "2020-04-23",
    "report_date": "2020-07-01",
    "classification_date": "2020-06-23",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac"
    ],
    "recall_numbers": [
     "D-1335-2020"
    ],
    "products": [
     "R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804,  NDC 70092143350"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2285547%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "84263",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "QuVa Pharma, Inc.",
    "firm_city": "Sugar Land",
    "firm_state": "TX",
    "date": "2019-11-12",
    "report_date": "2019-12-11",
    "classification_date": "2019-12-03",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules"
    ],
    "recall_numbers": [
     "D-0546-2020",
     "D-0547-2020",
     "D-0548-2020",
     "D-0549-2020",
     "D-0550-2020",
     "D-0551-2020",
     "D-0552-2020",
     "D-0553-2020",
     "D-0554-2020",
     "D-0555-2020",
     "D-0556-2020",
     "D-0557-2020",
     "D-0558-2020",
     "D-0559-2020",
     "D-0560-2020",
     "D-0561-2020",
     "D-0562-2020",
     "D-0563-2020",
     "D-0564-2020",
     "D-0565-2020",
     "D-0566-2020",
     "D-0567-2020",
     "D-0568-2020",
     "D-0569-2020",
     "D-0570-2020",
     "D-0571-2020",
     "D-0572-2020"
    ],
    "products": [
     "fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478  NDC 70092-1094-36",
     "fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478   NDC 70092-1100-50",
     "fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478   NDC 70092-1436-76",
     "fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478NDC 70092-1259-75",
     "fentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478  NDC 70092-1444-05"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2284263%22&limit=100",
    "classification": "Class II",
    "product_count": 27,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "81644",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "QuVa Pharma, Inc.",
    "firm_city": "Sugar Land",
    "firm_state": "TX",
    "date": "2018-11-21",
    "report_date": "2018-12-19",
    "classification_date": "2018-12-12",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride"
    ],
    "recall_numbers": [
     "D-0295-2019"
    ],
    "products": [
     "Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma 1075 West Park One Drive Suite 100 Sugar Land, TX 77478. Product Code 70092-9035-05"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2281644%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "80980",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "QuVa Pharma, Inc.",
    "firm_city": "Sugar Land",
    "firm_state": "TX",
    "date": "2018-08-27",
    "report_date": "2018-09-26",
    "classification_date": "2018-10-01",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug: Product may not have the active ingredient present in the bag."
    ],
    "recall_numbers": [
     "D-0003-2019"
    ],
    "products": [
     "Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2280980%22&limit=100",
    "classification": "Class I",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "73710",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "QuVa Pharma, Inc.",
    "firm_city": "Sugar Land",
    "firm_state": "TX",
    "date": "2016-03-30",
    "report_date": "2016-07-13",
    "classification_date": "2016-07-06",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe."
    ],
    "recall_numbers": [
     "D-1066-2016"
    ],
    "products": [
     "PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, packaged in 24 syringes per case, Rx only,  Healix Infusion Therapy Inc, 1075 W Park One Drive, Suite 200, Sugar Land Texas 77478, Product Code: 75901-1205-35."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2273710%22&limit=100",
    "classification": "Class I",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "recall",
    "event_id": "99311",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "QuVa Pharma, Inc.",
    "firm_city": "Sugar Land",
    "firm_state": "TX",
    "date": "2026-06-24",
    "report_date": "2026-07-15",
    "classification_date": "2026-07-07",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Failed Impurities/Degradation Specifications"
    ],
    "recall_numbers": [
     "D-0664-2026"
    ],
    "products": [
     "Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2299311%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "fmd145_letter",
    "date": "2026-05-05",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 05/05/2026",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "QuVa Pharma, Inc. Sugar Land, TX - 503B Facility"
   },
   {
    "type": "inspection",
    "date": "2026-05-04",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/193419/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-05-04",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/193419/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "recall",
    "event_id": "97790",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "QuVa Pharma, Inc.",
    "firm_city": "Sugar Land",
    "firm_state": "TX",
    "date": "2025-10-10",
    "report_date": "2025-11-05",
    "classification_date": "2025-10-27",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Particulate Matter"
    ],
    "recall_numbers": [
     "D-0113-2026"
    ],
    "products": [
     "R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use.  THIS IS A COMPOUNDED DRUG.  QuVA Pharma, 1075 Wes"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297790%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "untitled_letter",
    "date": "2025-06-18",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Untitled Letter Issued 06/18/2025",
    "url": "https://www.fda.gov/media/188151/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "QuVa Pharma, Inc. Sugar Land, TX - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "96446",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "QuVa Pharma, Inc.",
    "firm_city": "Sugar Land",
    "firm_state": "TX",
    "date": "2025-03-06",
    "report_date": "2025-04-02",
    "classification_date": "2025-03-25",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0295-2025",
     "D-0296-2025",
     "D-0297-2025"
    ],
    "products": [
     "fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Ph",
     "fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma,",
     "fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma,"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296446%22&limit=100",
    "classification": "Class II",
    "product_count": 3,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2024-10-28",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 10/28/2024 (PDF - 1.75MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/185187/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "QuVa Pharma, Inc. Sugar Land, TX - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2023-02-01",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 02/01/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "QuVa Pharma, Inc. Sugar Land, TX - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2023-01-24",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 01/24/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "QuVa Pharma, Inc. Sugar Land, TX - 503B Facility"
   },
   {
    "type": "483",
    "date": "2022-08-18",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 08/18/2022 (PDF - 638KB)",
    "url": "https://www.fda.gov/media/166635/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "QuVa Pharma, Inc. Sugar Land, TX - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "85773",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "QuVa Pharma, Inc.",
    "firm_city": "Sugar Land",
    "firm_state": "TX",
    "date": "2020-05-28",
    "report_date": "2020-06-17",
    "classification_date": "2020-06-11",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent drug - Product did not contain drug."
    ],
    "recall_numbers": [
     "D-1302-2020"
    ],
    "products": [
     "oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 888-339-0874, NDC 70092-1068-07"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2285773%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "85547",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "QuVa Pharma, Inc.",
    "firm_city": "Sugar Land",
    "firm_state": "TX",
    "date": "2020-04-23",
    "report_date": "2020-07-01",
    "classification_date": "2020-06-23",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac"
    ],
    "recall_numbers": [
     "D-1335-2020"
    ],
    "products": [
     "R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804,  NDC 70092143350"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2285547%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "84263",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "QuVa Pharma, Inc.",
    "firm_city": "Sugar Land",
    "firm_state": "TX",
    "date": "2019-11-12",
    "report_date": "2019-12-11",
    "classification_date": "2019-12-03",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules"
    ],
    "recall_numbers": [
     "D-0546-2020",
     "D-0547-2020",
     "D-0548-2020",
     "D-0549-2020",
     "D-0550-2020",
     "D-0551-2020",
     "D-0552-2020",
     "D-0553-2020",
     "D-0554-2020",
     "D-0555-2020",
     "D-0556-2020",
     "D-0557-2020",
     "D-0558-2020",
     "D-0559-2020",
     "D-0560-2020",
     "D-0561-2020",
     "D-0562-2020",
     "D-0563-2020",
     "D-0564-2020",
     "D-0565-2020",
     "D-0566-2020",
     "D-0567-2020",
     "D-0568-2020",
     "D-0569-2020",
     "D-0570-2020",
     "D-0571-2020",
     "D-0572-2020"
    ],
    "products": [
     "fentaNYL 2000 mcg/100 mL (20 mcg/mL) in 0.9% Sodium Chloride, 100 mL Bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478  NDC 70092-1094-36",
     "fentaNYL 2750 mcg/55 mL (50 mcg/mL) 55 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478   NDC 70092-1100-50",
     "fentaNYL 2500 mcg/50 mL (50 mcg/mL) 50 mL bag, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478   NDC 70092-1436-76",
     "fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478NDC 70092-1259-75",
     "fentaNYL 1250 mcg/250 mL (5 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478  NDC 70092-1444-05"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2284263%22&limit=100",
    "classification": "Class II",
    "product_count": 27,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2019-04-23",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 04/23/2019 (PDF - 693KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/124967/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "QuVa Pharma, Inc. Sugar Land, TX - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "81644",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "QuVa Pharma, Inc.",
    "firm_city": "Sugar Land",
    "firm_state": "TX",
    "date": "2018-11-21",
    "report_date": "2018-12-19",
    "classification_date": "2018-12-12",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride"
    ],
    "recall_numbers": [
     "D-0295-2019"
    ],
    "products": [
     "Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma 1075 West Park One Drive Suite 100 Sugar Land, TX 77478. Product Code 70092-9035-05"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2281644%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "80980",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "QuVa Pharma, Inc.",
    "firm_city": "Sugar Land",
    "firm_state": "TX",
    "date": "2018-08-27",
    "report_date": "2018-09-26",
    "classification_date": "2018-10-01",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug: Product may not have the active ingredient present in the bag."
    ],
    "recall_numbers": [
     "D-0003-2019"
    ],
    "products": [
     "Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2280980%22&limit=100",
    "classification": "Class I",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "73710",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "QuVa Pharma, Inc.",
    "firm_city": "Sugar Land",
    "firm_state": "TX",
    "date": "2016-03-30",
    "report_date": "2016-07-13",
    "classification_date": "2016-07-06",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe."
    ],
    "recall_numbers": [
     "D-1066-2016"
    ],
    "products": [
     "PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, packaged in 24 syringes per case, Rx only,  Healix Infusion Therapy Inc, 1075 W Park One Drive, Suite 200, Sugar Land Texas 77478, Product Code: 75901-1205-35."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2273710%22&limit=100",
    "classification": "Class I",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "counts": {
   "form483": 4,
   "warning_letters": 0,
   "recalls": 9,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Texas State Board of Pharmacy License Verification",
   "url": "https://www.pharmacy.texas.gov/dbsearch/phy_search.asp",
   "kind": "license lookup"
  },
  "state_name": "Texas"
 },
 {
  "listed_as": "RC Outsourcing, LLC, Lowellville, OH",
  "name": "RC Outsourcing, LLC",
  "city": "Lowellville",
  "state": "OH",
  "phone": "330-536-8500",
  "initial_registration": "10/7/2015",
  "initial_registration_date": "2015-10-07",
  "recent_registration": "11/27/2025",
  "recent_registration_date": "2025-11-27",
  "last_inspection": "9/3/2026",
  "last_inspection_date": "2026-09-03",
  "form483_issued": "Yes",
  "form483_links": [],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "rc-outsourcing-llc-lowellville-oh",
  "aliases": [
   "RC Outsourcing, LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "RC Outsourcing LLC, Lowellville, OH - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "97653",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "RC Outsourcing, LLC",
    "firm_city": "Lowellville",
    "firm_state": "OH",
    "date": "2025-09-22",
    "report_date": "2025-10-15",
    "classification_date": "2025-10-06",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of assurance of sterility."
    ],
    "recall_numbers": [
     "D-0003-2026"
    ],
    "products": [
     "Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297653%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-09-03",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-09-03",
    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table (no document link published there)",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "warning_letter",
    "date": "2026-03-20",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter (03/20/2026)",
    "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rc-outsourcing-llc-722877-03202026",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "RC Outsourcing LLC, Lowellville, OH - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "97653",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "RC Outsourcing, LLC",
    "firm_city": "Lowellville",
    "firm_state": "OH",
    "date": "2025-09-22",
    "report_date": "2025-10-15",
    "classification_date": "2025-10-06",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of assurance of sterility."
    ],
    "recall_numbers": [
     "D-0003-2026"
    ],
    "products": [
     "Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297653%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2025-08-28",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 08/28/2025",
    "url": "https://www.fda.gov/media/188813/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "RC Outsourcing LLC, Lowellville, OH - 503B Facility"
   },
   {
    "type": "483",
    "date": "2024-09-27",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 09/27/2024 (PDF - 1.79 MB)",
    "url": "https://www.fda.gov/media/184381/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "RC Outsourcing LLC, Lowellville, OH - 503B Facility"
   },
   {
    "type": "regulatory_meeting",
    "date": "2023-07-25",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Regulatory Meeting Held 07/25/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "RC Outsourcing LLC, Lowellville, OH - 503B Facility"
   },
   {
    "type": "483",
    "date": "2022-09-23",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 09/23/2022 (PDF - 1.97 MB)",
    "url": "https://www.fda.gov/media/165149/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "RC Outsourcing LLC, Lowellville, OH - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2020-05-22",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 05/22/2020 (PDF - 105 KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/139031/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "RC Outsourcing LLC, Lowellville, OH - 503B Facility"
   },
   {
    "type": "483",
    "date": "2019-02-08",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 02/08/2019 (PDF - 5.39 MB)",
    "url": "https://www.fda.gov/media/136444/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "RC Outsourcing LLC, Lowellville, OH - 503B Facility"
   }
  ],
  "counts": {
   "form483": 5,
   "warning_letters": 1,
   "recalls": 1,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Ohio eLicense Verification (Board of Pharmacy)",
   "url": "https://elicense.ohio.gov/oh_verifylicense",
   "kind": "license lookup"
  },
  "state_name": "Ohio"
 },
 {
  "listed_as": "Rapha Pharmaceuticals, lnc., Las Vegas, NV",
  "name": "Rapha Pharmaceuticals, lnc.",
  "city": "Las Vegas",
  "state": "NV",
  "phone": "1-407-362-7638",
  "initial_registration": "12/23/2024",
  "initial_registration_date": "2024-12-23",
  "recent_registration": "4/28/2026",
  "recent_registration_date": "2026-04-28",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "rapha-pharmaceuticals-lnc-las-vegas-nv",
  "aliases": [
   "Rapha Pharmaceuticals, lnc."
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Nevada State Board of Pharmacy",
   "url": "https://bop.nv.gov/",
   "kind": "board site"
  },
  "state_name": "Nevada"
 },
 {
  "listed_as": "Right Value Drug Stores, LLC, dba Carie Boyd's Prescription Shop, Irving, TX",
  "name": "Right Value Drug Stores, LLC, dba Carie Boyd's Prescription Shop",
  "city": "Irving",
  "state": "TX",
  "phone": "1-817-282-9376",
  "initial_registration": "7/3/2019",
  "initial_registration_date": "2019-07-03",
  "recent_registration": "9/8/2026",
  "recent_registration_date": "2026-09-08",
  "last_inspection": "7/18/2025",
  "last_inspection_date": "2025-07-18",
  "form483_issued": "Yes",
  "form483_links": [],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "right-value-drug-stores-llc-dba-carie-boyd-s-prescription-shop-irving-tx",
  "aliases": [
   "Right Value Drug Stores, LLC",
   "Carie Boyd's Prescription Shop"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Right Value Drug Store, Inc., (dba Carie Boyd\u2019s Prescription Shop), Hurst, TX - 503B Facility",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Hurst, TX); may be another site of the same company"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "93316",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop",
    "firm_city": "Irving",
    "firm_state": "TX",
    "date": "2023-11-09",
    "report_date": "2023-12-13",
    "classification_date": "2023-12-06",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Product Mix-up: Incorrect Product Formulation"
    ],
    "recall_numbers": [
     "D-0140-2024"
    ],
    "products": [
     "LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe, 10/pack, Rx only, Carie Boyd Pharmaceuticals, 8400 Esters Blvd, Ste# 190, Irving, TX 75063, NDC73271-1003-1"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293316%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "81198",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Hurst, TX); may be another site of the same company",
    "recalling_firm": "Right Value Drug Stores, Inc.",
    "firm_city": "Hurst",
    "firm_state": "TX",
    "date": "2018-09-25",
    "report_date": "2018-11-21",
    "classification_date": "2018-11-14",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling Not Elsewhere Classified: Misbranding."
    ],
    "recall_numbers": [
     "D-0240-2019",
     "D-0241-2019",
     "D-0242-2019",
     "D-0243-2019"
    ],
    "products": [
     "Tadalafil SR 12 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376  NDC 99999-9969-51",
     "Progesterone SR 200 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376. NDC 99999-0018-74",
     "Tadalafil SR 7 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054. NDC 99999-9970-88",
     "Progesterone SR 100 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376. NDC 99999-0104-55"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2281198%22&limit=100",
    "classification": "Class III",
    "product_count": 4,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "80655",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Hurst, TX); may be another site of the same company",
    "recalling_firm": "Right Value Drug Stores, Inc.",
    "firm_city": "Hurst",
    "firm_state": "TX",
    "date": "2018-07-26",
    "report_date": "2018-08-15",
    "classification_date": "2018-08-07",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label"
    ],
    "recall_numbers": [
     "D-1047-2018"
    ],
    "products": [
     "Testosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grapevine Hwy., Hurst, TX 76054, 800-930-4361"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2280655%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "70003",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Hurst, TX); may be another site of the same company",
    "recalling_firm": "Right Value Drug Stores, Inc.",
    "firm_city": "Hurst",
    "firm_state": "TX",
    "date": "2014-12-12",
    "report_date": "2015-01-14",
    "classification_date": "2015-01-08",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial."
    ],
    "recall_numbers": [
     "D-0335-2015"
    ],
    "products": [
     "Glutathione 200 mg/mL Injectable, packaged in a) 5 mL MDV (multiple dose vials), b) 30 mL MDV (multiple dose vials), and c) 100 mL MDV (multiple dose vials), Rx only, Carie Boyd's Prescription Shop, 122 Grapevine Highway, Hurst, TX 76054, ("
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2270003%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "483",
    "date": "2026-09-08",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Hurst, TX); may be another site of the same company",
    "text": "483 Issued 09/08/2026 (PDF - 1.34MB)",
    "url": "https://www.fda.gov/media/195071/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Right Value Drug Store, Inc., (dba Carie Boyd\u2019s Prescription Shop), Hurst, TX - 503B Facility"
   },
   {
    "type": "inspection",
    "date": "2025-07-18",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-07-18",
    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page (\"483 Issued 07/18/2025 (PDF - 1.60MB)\"). That listing is an uncertain match: Name and state match but a different city (Hurst, TX); may be another site of the same company",
    "url": "https://www.fda.gov/media/188174/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "warning_letter",
    "date": "2024-12-17",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Hurst, TX); may be another site of the same company",
    "text": "Warning Letter Issued 12/17/2024",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/right-value-drug-stores-llc-dba-carie-boyd-pharmaceuticals-694687-12172024",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Right Value Drug Store, Inc., (dba Carie Boyd\u2019s Prescription Shop), Hurst, TX - 503B Facility"
   },
   {
    "type": "483",
    "date": "2024-06-21",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Hurst, TX); may be another site of the same company",
    "text": "483 Issued 06/21/2024 (PDF 1.29MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/180071/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Right Value Drug Store, Inc., (dba Carie Boyd\u2019s Prescription Shop), Hurst, TX - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "93316",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop",
    "firm_city": "Irving",
    "firm_state": "TX",
    "date": "2023-11-09",
    "report_date": "2023-12-13",
    "classification_date": "2023-12-06",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Product Mix-up: Incorrect Product Formulation"
    ],
    "recall_numbers": [
     "D-0140-2024"
    ],
    "products": [
     "LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe, 10/pack, Rx only, Carie Boyd Pharmaceuticals, 8400 Esters Blvd, Ste# 190, Irving, TX 75063, NDC73271-1003-1"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293316%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "regulatory_meeting",
    "date": "2023-06-05",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Hurst, TX); may be another site of the same company",
    "text": "Regulatory Meeting Held 06/05/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Right Value Drug Store, Inc., (dba Carie Boyd\u2019s Prescription Shop), Hurst, TX - 503B Facility"
   },
   {
    "type": "483",
    "date": "2022-06-27",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Hurst, TX); may be another site of the same company",
    "text": "483 Issued 06/27/2022 (PDF - 2.4MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/163333/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Right Value Drug Store, Inc., (dba Carie Boyd\u2019s Prescription Shop), Hurst, TX - 503B Facility"
   },
   {
    "type": "warning_letter",
    "date": "2021-09-20",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Hurst, TX); may be another site of the same company",
    "text": "Warning Letter (09/20/2021)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apothecary-health-solutionsright-value-drug-stores-llc-dba-carie-boyds-prescription-shop-610751",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Right Value Drug Store, Inc., (dba Carie Boyd\u2019s Prescription Shop), Hurst, TX - 503B Facility"
   },
   {
    "type": "483",
    "date": "2019-11-12",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Hurst, TX); may be another site of the same company",
    "text": "483 Issued 11/12/2019 (PDF - 1.13MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/134260/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Right Value Drug Store, Inc., (dba Carie Boyd\u2019s Prescription Shop), Hurst, TX - 503B Facility"
   },
   {
    "type": "untitled_letter",
    "date": "2019-10-25",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Hurst, TX); may be another site of the same company",
    "text": "Untitled Letter Issued 10/25/2019 (PDF - 347KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/133593/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Right Value Drug Store, Inc., (dba Carie Boyd\u2019s Prescription Shop), Hurst, TX - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "81198",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Hurst, TX); may be another site of the same company",
    "recalling_firm": "Right Value Drug Stores, Inc.",
    "firm_city": "Hurst",
    "firm_state": "TX",
    "date": "2018-09-25",
    "report_date": "2018-11-21",
    "classification_date": "2018-11-14",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling Not Elsewhere Classified: Misbranding."
    ],
    "recall_numbers": [
     "D-0240-2019",
     "D-0241-2019",
     "D-0242-2019",
     "D-0243-2019"
    ],
    "products": [
     "Tadalafil SR 12 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376  NDC 99999-9969-51",
     "Progesterone SR 200 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376. NDC 99999-0018-74",
     "Tadalafil SR 7 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054. NDC 99999-9970-88",
     "Progesterone SR 100 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376. NDC 99999-0104-55"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2281198%22&limit=100",
    "classification": "Class III",
    "product_count": 4,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "80655",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Hurst, TX); may be another site of the same company",
    "recalling_firm": "Right Value Drug Stores, Inc.",
    "firm_city": "Hurst",
    "firm_state": "TX",
    "date": "2018-07-26",
    "report_date": "2018-08-15",
    "classification_date": "2018-08-07",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label"
    ],
    "recall_numbers": [
     "D-1047-2018"
    ],
    "products": [
     "Testosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grapevine Hwy., Hurst, TX 76054, 800-930-4361"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2280655%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "70003",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Hurst, TX); may be another site of the same company",
    "recalling_firm": "Right Value Drug Stores, Inc.",
    "firm_city": "Hurst",
    "firm_state": "TX",
    "date": "2014-12-12",
    "report_date": "2015-01-14",
    "classification_date": "2015-01-08",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial."
    ],
    "recall_numbers": [
     "D-0335-2015"
    ],
    "products": [
     "Glutathione 200 mg/mL Injectable, packaged in a) 5 mL MDV (multiple dose vials), b) 30 mL MDV (multiple dose vials), and c) 100 mL MDV (multiple dose vials), Rx only, Carie Boyd's Prescription Shop, 122 Grapevine Highway, Hurst, TX 76054, ("
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2270003%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "counts": {
   "form483": 1,
   "warning_letters": 0,
   "recalls": 1,
   "uncertain_items": 11
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Texas State Board of Pharmacy License Verification",
   "url": "https://www.pharmacy.texas.gov/dbsearch/phy_search.asp",
   "kind": "license lookup"
  },
  "state_name": "Texas"
 },
 {
  "listed_as": "Sankav Pharmaceuticals, LLC, Hackettstown, NJ",
  "name": "Sankav Pharmaceuticals, LLC",
  "city": "Hackettstown",
  "state": "NJ",
  "phone": "1-201-312-8591",
  "initial_registration": "3/21/2025",
  "initial_registration_date": "2025-03-21",
  "recent_registration": "12/23/2025",
  "recent_registration_date": "2025-12-23",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "sankav-pharmaceuticals-llc-hackettstown-nj",
  "aliases": [
   "Sankav Pharmaceuticals, LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "New Jersey Board of Pharmacy License Verification",
   "url": "https://newjersey.mylicense.com/verification/",
   "kind": "license lookup"
  },
  "state_name": "New Jersey"
 },
 {
  "listed_as": "SCA Pharmaceuticals, Little Rock, AR",
  "name": "SCA Pharmaceuticals",
  "city": "Little Rock",
  "state": "AR",
  "phone": "1-877-550-5059",
  "initial_registration": "12/13/2013",
  "initial_registration_date": "2013-12-13",
  "recent_registration": "12/5/2025",
  "recent_registration_date": "2025-12-05",
  "last_inspection": "10/30/2025",
  "last_inspection_date": "2025-10-30",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/190196/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Warning Letter Issued 9/14/2026",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "sca-pharmaceuticals-little-rock-ar",
  "aliases": [
   "SCA Pharmaceuticals"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "SCA Pharmaceuticals, LLC, Little Rock, AR - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "86982",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals, Inc.",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2020-12-14",
    "report_date": "2020-12-30",
    "classification_date": "2020-12-21",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent drug."
    ],
    "recall_numbers": [
     "D-0171-2021"
    ],
    "products": [
     "Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container, SCA Pharmaceuticals 8821 Knoedl Ct. Little Rock, AR 72205 Bar Code 70004093232"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2286982%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "80915",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals, Inc.",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2018-08-27",
    "report_date": "2018-09-19",
    "classification_date": "2018-09-12",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide."
    ],
    "recall_numbers": [
     "D-1189-2018"
    ],
    "products": [
     "Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205, 877.550.5059, barcode 70004063032."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2280915%22&limit=100",
    "classification": "Class I",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "80425",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2018-06-29",
    "report_date": "2018-07-18",
    "classification_date": "2018-07-12",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding."
    ],
    "recall_numbers": [
     "D-0918-2018"
    ],
    "products": [
     "Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205 877-550-5059"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2280425%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "78708",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2017-12-07",
    "report_date": "2018-01-17",
    "classification_date": "2018-01-05",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date."
    ],
    "recall_numbers": [
     "D-0156-2018"
    ],
    "products": [
     "Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only,  SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0600-12"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2278708%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "78320",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals, LLC",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2017-10-19",
    "report_date": "2017-11-08",
    "classification_date": "2017-11-02",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack Of Assurance Of Sterility."
    ],
    "recall_numbers": [
     "D-0059-2018",
     "D-0060-2018",
     "D-0061-2018",
     "D-0062-2018",
     "D-0063-2018",
     "D-0064-2018",
     "D-0065-2018",
     "D-0066-2018",
     "D-0067-2018",
     "D-0068-2018"
    ],
    "products": [
     "fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in 0.9% Sodium Chloride single dose CADD Cassette  Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0264-64",
     "oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0086-44",
     "fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40",
     "HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL)  Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17",
     "morphine sulfate 1 mg per mL in 0.9% Sodium Chloride  a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (NDC 70004-0100-63) b) Total Volume 50 mL in Single Dose Syringe (Total morphine Dose 50 mg / "
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2278320%22&limit=100",
    "classification": "Class II",
    "product_count": 10,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "77770",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2017-07-14",
    "report_date": "2017-08-02",
    "classification_date": "2017-07-26",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility; product has the potential to leak."
    ],
    "recall_numbers": [
     "D-1005-2017",
     "D-1006-2017",
     "D-1007-2017",
     "D-1008-2017",
     "D-1009-2017",
     "D-1010-2017",
     "D-1011-2017",
     "D-1012-2017",
     "D-1013-2017",
     "D-1014-2017",
     "D-1015-2017",
     "D-1016-2017",
     "D-1017-2017",
     "D-1018-2017",
     "D-1019-2017",
     "D-1020-2017",
     "D-1021-2017",
     "D-1022-2017",
     "D-1023-2017",
     "D-1024-2017",
     "D-1025-2017",
     "D-1026-2017",
     "D-1027-2017",
     "D-1028-2017",
     "D-1029-2017",
     "D-1030-2017",
     "D-1031-2017",
     "D-1032-2017",
     "D-1033-2017",
     "D-1034-2017"
    ],
    "products": [
     "PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40",
     "PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0809-40",
     "PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0816-40",
     "fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0202-40",
     "fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0260-40"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2277770%22&limit=100",
    "classification": "Class II",
    "product_count": 30,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "77777",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2017-07-14",
    "report_date": "2017-08-02",
    "classification_date": "2017-07-25",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak."
    ],
    "recall_numbers": [
     "D-0999-2017",
     "D-1000-2017",
     "D-1001-2017",
     "D-1002-2017",
     "D-1003-2017",
     "D-1004-2017"
    ],
    "products": [
     "Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0541-35.",
     "fentaNYL (as citrate) 10 mcg per mL  in 0.9% Sodium Chloride, (Total fentaNYL Dose 1,000 mcg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70",
     "ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0524-32.",
     "MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC:",
     "morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 100 mg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, (877) 550-5059; labeled as a) NDC"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2277777%22&limit=100",
    "classification": "Class II",
    "product_count": 6,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "77600",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2017-06-21",
    "report_date": "2017-07-19",
    "classification_date": "2017-07-13",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of sterility assurance"
    ],
    "recall_numbers": [
     "D-0976-2017",
     "D-0977-2017",
     "D-0978-2017",
     "D-0979-2017"
    ],
    "products": [
     "Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL,  Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-40",
     "Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq K+) Total Approximate Volume 260 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0843-40",
     "Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL,  Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-32",
     "Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0840-40"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2277600%22&limit=100",
    "classification": "Class II",
    "product_count": 4,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "77314",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2017-05-18",
    "report_date": "2017-06-07",
    "classification_date": "2017-05-31",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of assurance of sterility: Product bags leaking at seam."
    ],
    "recall_numbers": [
     "D-0870-2017",
     "D-0871-2017",
     "D-0872-2017",
     "D-0873-2017",
     "D-0874-2017",
     "D-0875-2017",
     "D-0876-2017",
     "D-0877-2017",
     "D-0878-2017",
     "D-0879-2017"
    ],
    "products": [
     "ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g,  Total Approximate Volume 100 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205,   NDC 70004-0522-32",
     "HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR",
     "morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL,  Single Dose Container bag, (Total morphine Dose 100 mg/ 100 mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Li",
     "fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR ",
     "MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock,"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2277314%22&limit=100",
    "classification": "Class II",
    "product_count": 10,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "76395",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2017-02-03",
    "report_date": "2017-04-12",
    "classification_date": "2017-04-05",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter."
    ],
    "recall_numbers": [
     "D-0639-2017",
     "D-0640-2017",
     "D-0641-2017",
     "D-0642-2017",
     "D-0643-2017",
     "D-0644-2017",
     "D-0645-2017"
    ],
    "products": [
     "Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0929-40",
     "Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0923-59",
     "Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0924-59",
     "Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0918-40",
     "Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0920-59"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2276395%22&limit=100",
    "classification": "Class I",
    "product_count": 7,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "71166",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2015-04-28",
    "report_date": "2015-06-17",
    "classification_date": "2015-06-10",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose."
    ],
    "recall_numbers": [
     "D-1133-2015"
    ],
    "products": [
     "PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0.2 mg per mL), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR (877) 550-5059, barcode 88888772029."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2271166%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "70583",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2015-02-24",
    "report_date": "2015-04-29",
    "classification_date": "2015-04-22",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of particulate."
    ],
    "recall_numbers": [
     "D-0965-2015"
    ],
    "products": [
     "Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syringe, packaged in 10-count syringes per heat sealed bag,  RX only; Compounded for Office Use by SCA Pharmaceuticals, Little Rock, AR (877 ) 550-5059 Bar Code 88888-77"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2270583%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "70167",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2015-01-02",
    "report_date": "2015-01-21",
    "classification_date": "2015-01-14",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the \"y\" and \"3\" making the actual \"Use By 3/2015\" date appear to read \"Use By8/2015\"."
    ],
    "recall_numbers": [
     "D-0339-2015"
    ],
    "products": [
     "Glycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syringe, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR  72205, 877-550-5059"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2270167%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "warning_letter",
    "date": "2026-09-14",
    "match": "table",
    "text": "Warning Letter Issued 9/14/2026",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483_response",
    "date": "2025-11-21",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Response Issued 11/21/2025 (PDF - 3.74MB)",
    "url": "https://www.fda.gov/media/193693/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "SCA Pharmaceuticals, LLC, Little Rock, AR - 503B Facility"
   },
   {
    "type": "inspection",
    "date": "2025-10-30",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/190196/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-10-30",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/190196/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "fmd145_letter",
    "date": "2023-09-29",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 9/29/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "SCA Pharmaceuticals, LLC, Little Rock, AR - 503B Facility"
   },
   {
    "type": "483",
    "date": "2023-05-17",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 05/17/2023 (PDF - 1 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/170293/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "SCA Pharmaceuticals, LLC, Little Rock, AR - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2021-08-19",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 08/19/2021",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "SCA Pharmaceuticals, LLC, Little Rock, AR - 503B Facility"
   },
   {
    "type": "warning_letter_closeout",
    "date": "2021-08-19",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter Close Out Issued 08/19/2021",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "SCA Pharmaceuticals, LLC, Little Rock, AR - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "86982",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals, Inc.",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2020-12-14",
    "report_date": "2020-12-30",
    "classification_date": "2020-12-21",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent drug."
    ],
    "recall_numbers": [
     "D-0171-2021"
    ],
    "products": [
     "Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container, SCA Pharmaceuticals 8821 Knoedl Ct. Little Rock, AR 72205 Bar Code 70004093232"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2286982%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2019-11-07",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 11/07/2019 (PDF - 724 KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/133949/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "SCA Pharmaceuticals, LLC, Little Rock, AR - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "80915",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals, Inc.",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2018-08-27",
    "report_date": "2018-09-19",
    "classification_date": "2018-09-12",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide."
    ],
    "recall_numbers": [
     "D-1189-2018"
    ],
    "products": [
     "Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205, 877.550.5059, barcode 70004063032."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2280915%22&limit=100",
    "classification": "Class I",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "80425",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2018-06-29",
    "report_date": "2018-07-18",
    "classification_date": "2018-07-12",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding."
    ],
    "recall_numbers": [
     "D-0918-2018"
    ],
    "products": [
     "Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205 877-550-5059"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2280425%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "78708",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2017-12-07",
    "report_date": "2018-01-17",
    "classification_date": "2018-01-05",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date."
    ],
    "recall_numbers": [
     "D-0156-2018"
    ],
    "products": [
     "Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only,  SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0600-12"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2278708%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "78320",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals, LLC",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2017-10-19",
    "report_date": "2017-11-08",
    "classification_date": "2017-11-02",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack Of Assurance Of Sterility."
    ],
    "recall_numbers": [
     "D-0059-2018",
     "D-0060-2018",
     "D-0061-2018",
     "D-0062-2018",
     "D-0063-2018",
     "D-0064-2018",
     "D-0065-2018",
     "D-0066-2018",
     "D-0067-2018",
     "D-0068-2018"
    ],
    "products": [
     "fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (200 mcg per 100 mL) in 0.9% Sodium Chloride single dose CADD Cassette  Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0264-64",
     "oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0086-44",
     "fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40",
     "HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL)  Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17",
     "morphine sulfate 1 mg per mL in 0.9% Sodium Chloride  a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (NDC 70004-0100-63) b) Total Volume 50 mL in Single Dose Syringe (Total morphine Dose 50 mg / "
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2278320%22&limit=100",
    "classification": "Class II",
    "product_count": 10,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "77770",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2017-07-14",
    "report_date": "2017-08-02",
    "classification_date": "2017-07-26",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility; product has the potential to leak."
    ],
    "recall_numbers": [
     "D-1005-2017",
     "D-1006-2017",
     "D-1007-2017",
     "D-1008-2017",
     "D-1009-2017",
     "D-1010-2017",
     "D-1011-2017",
     "D-1012-2017",
     "D-1013-2017",
     "D-1014-2017",
     "D-1015-2017",
     "D-1016-2017",
     "D-1017-2017",
     "D-1018-2017",
     "D-1019-2017",
     "D-1020-2017",
     "D-1021-2017",
     "D-1022-2017",
     "D-1023-2017",
     "D-1024-2017",
     "D-1025-2017",
     "D-1026-2017",
     "D-1027-2017",
     "D-1028-2017",
     "D-1029-2017",
     "D-1030-2017",
     "D-1031-2017",
     "D-1032-2017",
     "D-1033-2017",
     "D-1034-2017"
    ],
    "products": [
     "PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40",
     "PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0809-40",
     "PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0816-40",
     "fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0202-40",
     "fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0260-40"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2277770%22&limit=100",
    "classification": "Class II",
    "product_count": 30,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "77777",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2017-07-14",
    "report_date": "2017-08-02",
    "classification_date": "2017-07-25",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak."
    ],
    "recall_numbers": [
     "D-0999-2017",
     "D-1000-2017",
     "D-1001-2017",
     "D-1002-2017",
     "D-1003-2017",
     "D-1004-2017"
    ],
    "products": [
     "Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0541-35.",
     "fentaNYL (as citrate) 10 mcg per mL  in 0.9% Sodium Chloride, (Total fentaNYL Dose 1,000 mcg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70",
     "ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0524-32.",
     "MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC:",
     "morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 100 mg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, (877) 550-5059; labeled as a) NDC"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2277777%22&limit=100",
    "classification": "Class II",
    "product_count": 6,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "77600",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2017-06-21",
    "report_date": "2017-07-19",
    "classification_date": "2017-07-13",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of sterility assurance"
    ],
    "recall_numbers": [
     "D-0976-2017",
     "D-0977-2017",
     "D-0978-2017",
     "D-0979-2017"
    ],
    "products": [
     "Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL,  Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-40",
     "Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq K+) Total Approximate Volume 260 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0843-40",
     "Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL,  Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-32",
     "Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0840-40"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2277600%22&limit=100",
    "classification": "Class II",
    "product_count": 4,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "77314",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2017-05-18",
    "report_date": "2017-06-07",
    "classification_date": "2017-05-31",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of assurance of sterility: Product bags leaking at seam."
    ],
    "recall_numbers": [
     "D-0870-2017",
     "D-0871-2017",
     "D-0872-2017",
     "D-0873-2017",
     "D-0874-2017",
     "D-0875-2017",
     "D-0876-2017",
     "D-0877-2017",
     "D-0878-2017",
     "D-0879-2017"
    ],
    "products": [
     "ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g,  Total Approximate Volume 100 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205,   NDC 70004-0522-32",
     "HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR",
     "morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL,  Single Dose Container bag, (Total morphine Dose 100 mg/ 100 mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Li",
     "fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR ",
     "MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock,"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2277314%22&limit=100",
    "classification": "Class II",
    "product_count": 10,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "76395",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2017-02-03",
    "report_date": "2017-04-12",
    "classification_date": "2017-04-05",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter."
    ],
    "recall_numbers": [
     "D-0639-2017",
     "D-0640-2017",
     "D-0641-2017",
     "D-0642-2017",
     "D-0643-2017",
     "D-0644-2017",
     "D-0645-2017"
    ],
    "products": [
     "Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0929-40",
     "Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0923-59",
     "Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0924-59",
     "Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0918-40",
     "Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0920-59"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2276395%22&limit=100",
    "classification": "Class I",
    "product_count": 7,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "71166",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2015-04-28",
    "report_date": "2015-06-17",
    "classification_date": "2015-06-10",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose."
    ],
    "recall_numbers": [
     "D-1133-2015"
    ],
    "products": [
     "PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0.2 mg per mL), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR (877) 550-5059, barcode 88888772029."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2271166%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "70583",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2015-02-24",
    "report_date": "2015-04-29",
    "classification_date": "2015-04-22",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of particulate."
    ],
    "recall_numbers": [
     "D-0965-2015"
    ],
    "products": [
     "Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syringe, packaged in 10-count syringes per heat sealed bag,  RX only; Compounded for Office Use by SCA Pharmaceuticals, Little Rock, AR (877 ) 550-5059 Bar Code 88888-77"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2270583%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "70167",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Little Rock",
    "firm_state": "AR",
    "date": "2015-01-02",
    "report_date": "2015-01-21",
    "classification_date": "2015-01-14",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the \"y\" and \"3\" making the actual \"Use By 3/2015\" date appear to read \"Use By8/2015\"."
    ],
    "recall_numbers": [
     "D-0339-2015"
    ],
    "products": [
     "Glycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syringe, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR  72205, 877-550-5059"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2270167%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "counts": {
   "form483": 3,
   "warning_letters": 1,
   "recalls": 13,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Arkansas State Board of Pharmacy",
   "url": "https://www.pharmacyboard.arkansas.gov/",
   "kind": "board site"
  },
  "state_name": "Arkansas"
 },
 {
  "listed_as": "SCA Pharmaceuticals, Windsor, CT",
  "name": "SCA Pharmaceuticals",
  "city": "Windsor",
  "state": "CT",
  "phone": "877-550-5059",
  "initial_registration": "8/3/2017",
  "initial_registration_date": "2017-08-03",
  "recent_registration": "12/8/2025",
  "recent_registration_date": "2025-12-08",
  "last_inspection": "3/13/2026",
  "last_inspection_date": "2026-03-13",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/192262/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Open7",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "sca-pharmaceuticals-windsor-ct",
  "aliases": [
   "SCA Pharmaceuticals"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "SCA Pharmaceuticals, LLC., Windsor, CT - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "93456",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals, LLC",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2023-11-09",
    "report_date": "2024-04-03",
    "classification_date": "2024-03-22",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0394-2024",
     "D-0395-2024",
     "D-0396-2024",
     "D-0397-2024",
     "D-0398-2024",
     "D-0399-2024",
     "D-0400-2024",
     "D-0401-2024",
     "D-0402-2024",
     "D-0403-2024",
     "D-0404-2024",
     "D-0405-2024",
     "D-0406-2024",
     "D-0407-2024",
     "D-0408-2024",
     "D-0409-2024",
     "D-0410-2024",
     "D-0411-2024",
     "D-0412-2024",
     "D-0413-2024",
     "D-0414-2024",
     "D-0415-2024",
     "D-0416-2024",
     "D-0417-2024",
     "D-0418-2024",
     "D-0419-2024",
     "D-0420-2024",
     "D-0421-2024",
     "D-0422-2024",
     "D-0423-2024",
     "D-0424-2024",
     "D-0425-2024"
    ],
    "products": [
     "PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.",
     "labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028",
     "HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095,  NDC 70004-0303-21, Bar Code 70004030321",
     "PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540.",
     "fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC 70004-02"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293456%22&limit=100",
    "classification": "Class II",
    "product_count": 32,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "92737",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2023-07-20",
    "report_date": "2023-08-02",
    "classification_date": "2023-07-26",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "cGMP deviations: due to shipment of rejected units."
    ],
    "recall_numbers": [
     "D-0945-2023"
    ],
    "products": [
     "FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 7"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2292737%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "92073",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2023-04-10",
    "report_date": "2023-05-03",
    "classification_date": "2023-04-27",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug: Out of specification results for low potency was obtained."
    ],
    "recall_numbers": [
     "D-0555-2023"
    ],
    "products": [
     "Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2292073%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "91774",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2023-02-24",
    "report_date": "2023-03-08",
    "classification_date": "2023-02-28",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug"
    ],
    "recall_numbers": [
     "D-0363-2023"
    ],
    "products": [
     "Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291774%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "90080",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2022-04-25",
    "report_date": "2022-05-11",
    "classification_date": "2022-05-02",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "CGMP Deviations"
    ],
    "recall_numbers": [
     "D-0829-2022",
     "D-0830-2022",
     "D-0831-2022"
    ],
    "products": [
     "Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44",
     "Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40",
     "Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2290080%22&limit=100",
    "classification": "Class II",
    "product_count": 3,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "86990",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2020-12-17",
    "report_date": "2021-01-13",
    "classification_date": "2021-01-07",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit"
    ],
    "recall_numbers": [
     "D-0186-2021",
     "D-0187-2021",
     "D-0188-2021",
     "D-0189-2021",
     "D-0190-2021",
     "D-0191-2021",
     "D-0192-2021",
     "D-0193-2021",
     "D-0194-2021",
     "D-0195-2021",
     "D-0196-2021",
     "D-0197-2021",
     "D-0198-2021",
     "D-0199-2021",
     "D-0200-2021",
     "D-0201-2021",
     "D-0202-2021",
     "D-0203-2021",
     "D-0204-2021",
     "D-0205-2021",
     "D-0206-2021",
     "D-0207-2021",
     "D-0208-2021",
     "D-0209-2021",
     "D-0210-2021",
     "D-0211-2021",
     "D-0212-2021",
     "D-0213-2021",
     "D-0214-2021",
     "D-0215-2021",
     "D-0216-2021",
     "D-0217-2021"
    ],
    "products": [
     "HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004030022",
     "ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412",
     "PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022",
     "ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe,  SCA Pharmaceuticals 8521 Knoedl Ct., Little Rock, AR, 72205, barcode 70004060409",
     "fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only,  SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004026422"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2286990%22&limit=100",
    "classification": "Class II, Class III",
    "product_count": 32,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "86802",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2020-11-20",
    "report_date": "2020-12-23",
    "classification_date": "2020-12-14",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotency: Out-of-specification stability test result for low potency was obtained."
    ],
    "recall_numbers": [
     "D-0147-2021"
    ],
    "products": [
     "Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2286802%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "86193",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2020-07-29",
    "report_date": "2020-09-02",
    "classification_date": "2020-08-27",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens."
    ],
    "recall_numbers": [
     "D-1550-2020",
     "D-1551-2020",
     "D-1552-2020",
     "D-1553-2020"
    ],
    "products": [
     "Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0652-46, Bar Code 70004065246.",
     "Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0655-44, Bar Code 70004065544.",
     "Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-46, Bar Code 70004065046.",
     "Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-44, Bar Code 70004065044."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2286193%22&limit=100",
    "classification": "Class I",
    "product_count": 4,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "86194",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2020-07-29",
    "report_date": "2020-08-19",
    "classification_date": "2020-08-12",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint."
    ],
    "recall_numbers": [
     "D-1495-2020"
    ],
    "products": [
     "Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2286194%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "85865",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2020-06-16",
    "report_date": "2020-06-24",
    "classification_date": "2020-06-17",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint."
    ],
    "recall_numbers": [
     "D-1311-2020"
    ],
    "products": [
     "Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2285865%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "84326",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals, LLC",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2019-11-26",
    "report_date": "2019-12-18",
    "classification_date": "2019-12-10",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Foreign Substance: Foreign material found inside the vial (manufacturer)."
    ],
    "recall_numbers": [
     "D-0620-2020"
    ],
    "products": [
     "Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695   NDC 70004-0723-09"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2284326%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "83580",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals, LLC",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2019-08-16",
    "report_date": "2019-08-28",
    "classification_date": "2019-08-26",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility."
    ],
    "recall_numbers": [
     "D-1843-2019"
    ],
    "products": [
     "Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2283580%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "80303",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals, LLC",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2018-06-14",
    "report_date": "2018-07-11",
    "classification_date": "2018-07-02",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage."
    ],
    "recall_numbers": [
     "D-0894-2018",
     "D-0895-2018",
     "D-0896-2018",
     "D-0897-2018",
     "D-0898-2018",
     "D-0899-2018",
     "D-0900-2018",
     "D-0901-2018",
     "D-0902-2018",
     "D-0903-2018",
     "D-0904-2018",
     "D-0905-2018"
    ],
    "products": [
     "Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT",
     "Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT",
     "Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT",
     "Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT",
     "Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2280303%22&limit=100",
    "classification": "Class II",
    "product_count": 12,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "79265",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals, LLC.",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2018-02-22",
    "report_date": "2018-03-14",
    "classification_date": "2018-03-19",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018"
    ],
    "recall_numbers": [
     "D-0603-2018"
    ],
    "products": [
     "labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2279265%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-03-13",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/192262/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-03-13",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/192262/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "fmd145_letter",
    "date": "2025-04-17",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 04/17/2025",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "SCA Pharmaceuticals, LLC., Windsor, CT - 503B Facility"
   },
   {
    "type": "483",
    "date": "2024-12-20",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 12/20/2024 (PDF - 2.45 MB)",
    "url": "https://www.fda.gov/media/185240/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "SCA Pharmaceuticals, LLC., Windsor, CT - 503B Facility"
   },
   {
    "type": "483_response",
    "date": "2023-11-10",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Response Dated 11/10/2023 (PDF - 360 KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/174928/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "SCA Pharmaceuticals, LLC., Windsor, CT - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "93456",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals, LLC",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2023-11-09",
    "report_date": "2024-04-03",
    "classification_date": "2024-03-22",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0394-2024",
     "D-0395-2024",
     "D-0396-2024",
     "D-0397-2024",
     "D-0398-2024",
     "D-0399-2024",
     "D-0400-2024",
     "D-0401-2024",
     "D-0402-2024",
     "D-0403-2024",
     "D-0404-2024",
     "D-0405-2024",
     "D-0406-2024",
     "D-0407-2024",
     "D-0408-2024",
     "D-0409-2024",
     "D-0410-2024",
     "D-0411-2024",
     "D-0412-2024",
     "D-0413-2024",
     "D-0414-2024",
     "D-0415-2024",
     "D-0416-2024",
     "D-0417-2024",
     "D-0418-2024",
     "D-0419-2024",
     "D-0420-2024",
     "D-0421-2024",
     "D-0422-2024",
     "D-0423-2024",
     "D-0424-2024",
     "D-0425-2024"
    ],
    "products": [
     "PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.",
     "labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028",
     "HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095,  NDC 70004-0303-21, Bar Code 70004030321",
     "PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540.",
     "fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC 70004-02"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293456%22&limit=100",
    "classification": "Class II",
    "product_count": 32,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2023-10-20",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 10/20/2023 (PDF - 642 KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/174927/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "SCA Pharmaceuticals, LLC., Windsor, CT - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "92737",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2023-07-20",
    "report_date": "2023-08-02",
    "classification_date": "2023-07-26",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "cGMP deviations: due to shipment of rejected units."
    ],
    "recall_numbers": [
     "D-0945-2023"
    ],
    "products": [
     "FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 7"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2292737%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "92073",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2023-04-10",
    "report_date": "2023-05-03",
    "classification_date": "2023-04-27",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug: Out of specification results for low potency was obtained."
    ],
    "recall_numbers": [
     "D-0555-2023"
    ],
    "products": [
     "Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2292073%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "91774",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2023-02-24",
    "report_date": "2023-03-08",
    "classification_date": "2023-02-28",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug"
    ],
    "recall_numbers": [
     "D-0363-2023"
    ],
    "products": [
     "Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2291774%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "90080",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2022-04-25",
    "report_date": "2022-05-11",
    "classification_date": "2022-05-02",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "CGMP Deviations"
    ],
    "recall_numbers": [
     "D-0829-2022",
     "D-0830-2022",
     "D-0831-2022"
    ],
    "products": [
     "Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44",
     "Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40",
     "Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2290080%22&limit=100",
    "classification": "Class II",
    "product_count": 3,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "fmd145_letter",
    "date": "2021-10-22",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 10/22/2021",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "SCA Pharmaceuticals, LLC., Windsor, CT - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "86990",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2020-12-17",
    "report_date": "2021-01-13",
    "classification_date": "2021-01-07",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit"
    ],
    "recall_numbers": [
     "D-0186-2021",
     "D-0187-2021",
     "D-0188-2021",
     "D-0189-2021",
     "D-0190-2021",
     "D-0191-2021",
     "D-0192-2021",
     "D-0193-2021",
     "D-0194-2021",
     "D-0195-2021",
     "D-0196-2021",
     "D-0197-2021",
     "D-0198-2021",
     "D-0199-2021",
     "D-0200-2021",
     "D-0201-2021",
     "D-0202-2021",
     "D-0203-2021",
     "D-0204-2021",
     "D-0205-2021",
     "D-0206-2021",
     "D-0207-2021",
     "D-0208-2021",
     "D-0209-2021",
     "D-0210-2021",
     "D-0211-2021",
     "D-0212-2021",
     "D-0213-2021",
     "D-0214-2021",
     "D-0215-2021",
     "D-0216-2021",
     "D-0217-2021"
    ],
    "products": [
     "HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, 50 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004030022",
     "ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412",
     "PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022",
     "ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single Dose Syringe,  SCA Pharmaceuticals 8521 Knoedl Ct., Little Rock, AR, 72205, barcode 70004060409",
     "fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only,  SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004026422"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2286990%22&limit=100",
    "classification": "Class II, Class III",
    "product_count": 32,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "86802",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2020-11-20",
    "report_date": "2020-12-23",
    "classification_date": "2020-12-14",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotency: Out-of-specification stability test result for low potency was obtained."
    ],
    "recall_numbers": [
     "D-0147-2021"
    ],
    "products": [
     "Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2286802%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "86193",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2020-07-29",
    "report_date": "2020-09-02",
    "classification_date": "2020-08-27",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens."
    ],
    "recall_numbers": [
     "D-1550-2020",
     "D-1551-2020",
     "D-1552-2020",
     "D-1553-2020"
    ],
    "products": [
     "Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0652-46, Bar Code 70004065246.",
     "Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0655-44, Bar Code 70004065544.",
     "Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-46, Bar Code 70004065046.",
     "Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10 units/mL), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC#: 70004-0650-44, Bar Code 70004065044."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2286193%22&limit=100",
    "classification": "Class I",
    "product_count": 4,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "86194",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2020-07-29",
    "report_date": "2020-08-19",
    "classification_date": "2020-08-12",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint."
    ],
    "recall_numbers": [
     "D-1495-2020"
    ],
    "products": [
     "Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2286194%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "85865",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2020-06-16",
    "report_date": "2020-06-24",
    "classification_date": "2020-06-17",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint."
    ],
    "recall_numbers": [
     "D-1311-2020"
    ],
    "products": [
     "Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2285865%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "84326",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals, LLC",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2019-11-26",
    "report_date": "2019-12-18",
    "classification_date": "2019-12-10",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Foreign Substance: Foreign material found inside the vial (manufacturer)."
    ],
    "recall_numbers": [
     "D-0620-2020"
    ],
    "products": [
     "Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695   NDC 70004-0723-09"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2284326%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2019-11-19",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 11/19/2019 (PDF - 1 MB)",
    "url": "https://www.fda.gov/media/134901/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "SCA Pharmaceuticals, LLC., Windsor, CT - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "83580",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals, LLC",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2019-08-16",
    "report_date": "2019-08-28",
    "classification_date": "2019-08-26",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility."
    ],
    "recall_numbers": [
     "D-1843-2019"
    ],
    "products": [
     "Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2283580%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "80303",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals, LLC",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2018-06-14",
    "report_date": "2018-07-11",
    "classification_date": "2018-07-02",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage."
    ],
    "recall_numbers": [
     "D-0894-2018",
     "D-0895-2018",
     "D-0896-2018",
     "D-0897-2018",
     "D-0898-2018",
     "D-0899-2018",
     "D-0900-2018",
     "D-0901-2018",
     "D-0902-2018",
     "D-0903-2018",
     "D-0904-2018",
     "D-0905-2018"
    ],
    "products": [
     "Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT",
     "Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT",
     "Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT",
     "Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT",
     "Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2280303%22&limit=100",
    "classification": "Class II",
    "product_count": 12,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "79265",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "SCA Pharmaceuticals, LLC.",
    "firm_city": "Windsor",
    "firm_state": "CT",
    "date": "2018-02-22",
    "report_date": "2018-03-14",
    "classification_date": "2018-03-19",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018"
    ],
    "recall_numbers": [
     "D-0603-2018"
    ],
    "products": [
     "labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2279265%22&limit=100",
    "classification": "Class III",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "counts": {
   "form483": 4,
   "warning_letters": 0,
   "recalls": 14,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Connecticut eLicense Lookup (Commission of Pharmacy)",
   "url": "https://www.elicense.ct.gov/Lookup/LicenseLookup.aspx",
   "kind": "license lookup"
  },
  "state_name": "Connecticut"
 },
 {
  "listed_as": "Signature Rx, Delray Beach, FL",
  "name": "Signature Rx",
  "city": "Delray Beach",
  "state": "FL",
  "phone": "1-401-249-1963",
  "initial_registration": "10/13/2023",
  "initial_registration_date": "2023-10-13",
  "recent_registration": "8/31/2026",
  "recent_registration_date": "2026-08-31",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "signature-rx-delray-beach-fl",
  "aliases": [
   "Signature Rx"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Florida Department of Health License Verification (Board of Pharmacy)",
   "url": "https://mqa-internet.doh.state.fl.us/MQASearchServices/Home",
   "kind": "license lookup"
  },
  "state_name": "Florida"
 },
 {
  "listed_as": "Simple RX Solutions, P.C., Lewisburg, TN",
  "name": "Simple RX Solutions, P.C.",
  "city": "Lewisburg",
  "state": "TN",
  "phone": "1-972-890-4743",
  "initial_registration": "8/26/2026",
  "initial_registration_date": "2026-08-26",
  "recent_registration": "8/26/2026",
  "recent_registration_date": "2026-08-26",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "simple-rx-solutions-p-c-lewisburg-tn",
  "aliases": [
   "Simple RX Solutions, P.C."
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Tennessee Department of Health Licensure Verification (Board of Pharmacy)",
   "url": "https://apps.health.tn.gov/Licensure/",
   "kind": "license lookup"
  },
  "state_name": "Tennessee"
 },
 {
  "listed_as": "SKNV formerly registered as Sincerus Florida, LLC, Pompano Beach, FL",
  "name": "SKNV formerly registered as Sincerus Florida, LLC",
  "city": "Pompano Beach",
  "state": "FL",
  "phone": "800-604-5032 Ext 313",
  "initial_registration": "3/10/2016",
  "initial_registration_date": "2016-03-10",
  "recent_registration": "12/3/2025",
  "recent_registration_date": "2025-12-03",
  "last_inspection": "5/29/2026",
  "last_inspection_date": "2026-05-29",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/193727/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "sknv-formerly-registered-as-sincerus-florida-llc-pompano-beach-fl",
  "aliases": [
   "SKNV",
   "Sincerus Florida, LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "SKNV (formerly Sincerus Florida LLC), Pompano Beach FL - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-05-29",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/193727/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-05-29",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/193727/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "fmd145_letter",
    "date": "2026-04-22",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 04/22/2026",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "SKNV (formerly Sincerus Florida LLC), Pompano Beach FL - 503B Facility"
   },
   {
    "type": "untitled_letter",
    "date": "2025-09-16",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Untitled Letter Issued 09/16/2025",
    "url": "https://www.fda.gov/media/190197/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "SKNV (formerly Sincerus Florida LLC), Pompano Beach FL - 503B Facility"
   },
   {
    "type": "483",
    "date": "2025-03-06",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 03/06/2025 (PDF - 698KB)",
    "url": "https://www.fda.gov/media/186005/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "SKNV (formerly Sincerus Florida LLC), Pompano Beach FL - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2024-09-30",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 09/30/2024",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "SKNV (formerly Sincerus Florida LLC), Pompano Beach FL - 503B Facility"
   },
   {
    "type": "483",
    "date": "2024-05-23",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 05/23/2024 (PDF - 227KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/180708/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "SKNV (formerly Sincerus Florida LLC), Pompano Beach FL - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2020-11-16",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 11/16/2020 (PDF - 209KB)",
    "url": "https://www.fda.gov/media/144726/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "SKNV (formerly Sincerus Florida LLC), Pompano Beach FL - 503B Facility"
   }
  ],
  "counts": {
   "form483": 3,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Florida Department of Health License Verification (Board of Pharmacy)",
   "url": "https://mqa-internet.doh.state.fl.us/MQASearchServices/Home",
   "kind": "license lookup"
  },
  "state_name": "Florida"
 },
 {
  "listed_as": "STAQ Pharma, Inc., Denver, CO",
  "name": "STAQ Pharma, Inc.",
  "city": "Denver",
  "state": "CO",
  "phone": "1-303-921-5789",
  "initial_registration": "2/5/2019",
  "initial_registration_date": "2019-02-05",
  "recent_registration": "12/18/2025",
  "recent_registration_date": "2025-12-18",
  "last_inspection": "9/8/2026",
  "last_inspection_date": "2026-09-08",
  "form483_issued": "Yes",
  "form483_links": [],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "staq-pharma-inc-denver-co",
  "aliases": [
   "STAQ Pharma, Inc."
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "STAQ Pharma, Inc., Denver, CO - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "97779",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "STAQ Pharma, Inc.",
    "firm_city": "Denver",
    "firm_state": "CO",
    "date": "2025-10-09",
    "report_date": "2025-10-22",
    "classification_date": "2025-10-15",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Incorrect or Missing Lot and/or Exp Date"
    ],
    "recall_numbers": [
     "D-0023-2026",
     "D-0024-2026",
     "D-0025-2026"
    ],
    "products": [
     "Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.",
     "Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05.",
     "FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297779%22&limit=100",
    "classification": "Class III",
    "product_count": 3,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "93505",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "STAQ Pharma, Inc.",
    "firm_city": "Denver",
    "firm_state": "CO",
    "date": "2023-11-29",
    "report_date": "2023-12-13",
    "classification_date": "2023-12-07",
    "status": "Completed",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks."
    ],
    "recall_numbers": [
     "D-0147-2024"
    ],
    "products": [
     "ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, Unit 50, Denver, Colorado 80239, NDC 73177-0109-26,"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293505%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "89550",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "STAQ Pharma, Inc.",
    "firm_city": "Denver",
    "firm_state": "CO",
    "date": "2022-02-03",
    "report_date": "2022-02-23",
    "classification_date": "2022-02-25",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A"
    ],
    "recall_numbers": [
     "D-0633-2022",
     "D-0634-2022"
    ],
    "products": [
     "HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0104-05.",
     "Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0105-04."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2289550%22&limit=100",
    "classification": "Class I",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-09-08",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-09-08",
    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table (no document link published there)",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "recall",
    "event_id": "97779",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "STAQ Pharma, Inc.",
    "firm_city": "Denver",
    "firm_state": "CO",
    "date": "2025-10-09",
    "report_date": "2025-10-22",
    "classification_date": "2025-10-15",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Incorrect or Missing Lot and/or Exp Date"
    ],
    "recall_numbers": [
     "D-0023-2026",
     "D-0024-2026",
     "D-0025-2026"
    ],
    "products": [
     "Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.",
     "Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05.",
     "FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2297779%22&limit=100",
    "classification": "Class III",
    "product_count": 3,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "fmd145_letter",
    "date": "2025-06-06",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 06/06/2025",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "STAQ Pharma, Inc., Denver, CO - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "93505",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "STAQ Pharma, Inc.",
    "firm_city": "Denver",
    "firm_state": "CO",
    "date": "2023-11-29",
    "report_date": "2023-12-13",
    "classification_date": "2023-12-07",
    "status": "Completed",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks."
    ],
    "recall_numbers": [
     "D-0147-2024"
    ],
    "products": [
     "ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, Unit 50, Denver, Colorado 80239, NDC 73177-0109-26,"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2293505%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "fmd145_letter",
    "date": "2022-03-25",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 03/25/2022",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "STAQ Pharma, Inc., Denver, CO - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "89550",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "STAQ Pharma, Inc.",
    "firm_city": "Denver",
    "firm_state": "CO",
    "date": "2022-02-03",
    "report_date": "2022-02-23",
    "classification_date": "2022-02-25",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A"
    ],
    "recall_numbers": [
     "D-0633-2022",
     "D-0634-2022"
    ],
    "products": [
     "HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0104-05.",
     "Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0105-04."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2289550%22&limit=100",
    "classification": "Class I",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2021-09-29",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 09/29/2021 (PDF - 3 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/158588/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "STAQ Pharma, Inc., Denver, CO - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2021-05-25",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 05/25/2021",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "STAQ Pharma, Inc., Denver, CO - 503B Facility"
   },
   {
    "type": "483",
    "date": "2020-09-03",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 09/03/2020 (PDF - 877 KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/143121/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "STAQ Pharma, Inc., Denver, CO - 503B Facility"
   }
  ],
  "counts": {
   "form483": 3,
   "warning_letters": 0,
   "recalls": 3,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Colorado DORA License Lookup (State Board of Pharmacy)",
   "url": "https://apps2.colorado.gov/dora/licensing/Lookup/LicenseLookup.aspx",
   "kind": "license lookup"
  },
  "state_name": "Colorado"
 },
 {
  "listed_as": "STAQ Pharma of Ohio, LLC, Columbus, OH",
  "name": "STAQ Pharma of Ohio, LLC",
  "city": "Columbus",
  "state": "OH",
  "phone": "1-303-921-5789",
  "initial_registration": "1/26/2023",
  "initial_registration_date": "2023-01-26",
  "recent_registration": "12/18/2025",
  "recent_registration_date": "2025-12-18",
  "last_inspection": "8/19/2026",
  "last_inspection_date": "2026-08-19",
  "form483_issued": "Yes",
  "form483_links": [],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "staq-pharma-of-ohio-llc-columbus-oh",
  "aliases": [
   "STAQ Pharma of Ohio, LLC"
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  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-08-19",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-08-19",
    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table (no document link published there)",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   }
  ],
  "counts": {
   "form483": 1,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Ohio eLicense Verification (Board of Pharmacy)",
   "url": "https://elicense.ohio.gov/oh_verifylicense",
   "kind": "license lookup"
  },
  "state_name": "Ohio"
 },
 {
  "listed_as": "Staska Pharmaceuticals, Inc., Bennet, NE",
  "name": "Staska Pharmaceuticals, Inc.",
  "city": "Bennet",
  "state": "NE",
  "phone": "402-782-2207",
  "initial_registration": "12/3/2020",
  "initial_registration_date": "2020-12-03",
  "recent_registration": "12/12/2025",
  "recent_registration_date": "2025-12-12",
  "last_inspection": "2/20/2026",
  "last_inspection_date": "2026-02-20",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/192261/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "staska-pharmaceuticals-inc-bennet-ne",
  "aliases": [
   "Staska Pharmaceuticals, Inc."
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Staska Pharmaceuticals, Inc., Bennet, NE - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "95503",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Staska Pharmaceuticals, Inc.",
    "firm_city": "Bennet",
    "firm_state": "NE",
    "date": "2024-09-30",
    "report_date": "2024-11-13",
    "classification_date": "2024-11-07",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Particulate Matter: Presence of glass particulates."
    ],
    "recall_numbers": [
     "D-0040-2025"
    ],
    "products": [
     "Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2295503%22&limit=100",
    "classification": "Class I",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-02-20",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/192261/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-02-20",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/192261/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "warning_letter",
    "date": "2025-05-05",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter (05/05/2025)",
    "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/staska-pharmaceuticals-inc-699291-05052025",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Staska Pharmaceuticals, Inc., Bennet, NE - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "95503",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Staska Pharmaceuticals, Inc.",
    "firm_city": "Bennet",
    "firm_state": "NE",
    "date": "2024-09-30",
    "report_date": "2024-11-13",
    "classification_date": "2024-11-07",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Presence of Particulate Matter: Presence of glass particulates."
    ],
    "recall_numbers": [
     "D-0040-2025"
    ],
    "products": [
     "Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2295503%22&limit=100",
    "classification": "Class I",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2024-09-26",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Amended 483 Issued 09/26/2024 (PDF - 1.88 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/183268/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Staska Pharmaceuticals, Inc., Bennet, NE - 503B Facility"
   },
   {
    "type": "recall_notice",
    "date": null,
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Firm Press Release: Staska Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL Due to the Presence of Glass Particles | FDA",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/staska-pharmaceuticals-inc-issues-voluntary-nationwide-recall-ascorbic-acid-solution-injection?utm_medium=email&utm_source=govdelivery#recall-announcement",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Staska Pharmaceuticals, Inc., Bennet, NE - 503B Facility"
   }
  ],
  "counts": {
   "form483": 2,
   "warning_letters": 1,
   "recalls": 1,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Nebraska DHHS License Information System (Pharmacy)",
   "url": "https://www.nebraska.gov/LISSearch/search.cgi",
   "kind": "license lookup"
  },
  "state_name": "Nebraska"
 },
 {
  "listed_as": "Stokes Healthcare Inc., dba Epicur Pharma, Mt. Laurel, NJ",
  "name": "Stokes Healthcare Inc., dba Epicur Pharma",
  "city": "Mt. Laurel",
  "state": "NJ",
  "phone": "888-508-5032",
  "initial_registration": "1/30/2018",
  "initial_registration_date": "2018-01-30",
  "recent_registration": "11/19/2025",
  "recent_registration_date": "2025-11-19",
  "last_inspection": "5/23/2025",
  "last_inspection_date": "2025-05-23",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/177221/download?attachment"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "stokes-healthcare-inc-dba-epicur-pharma-mt-laurel-nj",
  "aliases": [
   "Stokes Healthcare Inc.",
   "Epicur Pharma"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Stokes Healthcare Inc., (dba Epicur Pharma), Mount Laurel, NJ - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "inspection",
    "date": "2025-05-23",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/177221/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-05-23",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/177221/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "warning_letter",
    "date": "2024-04-02",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter (04/02/2024)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stokes-healthcare-inc-dba-epicur-pharma-677624-04022024",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Stokes Healthcare Inc., (dba Epicur Pharma), Mount Laurel, NJ - 503B Facility"
   },
   {
    "type": "483",
    "date": "2023-10-25",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 10/25/2023 (PDF - 14MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/177221/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Stokes Healthcare Inc., (dba Epicur Pharma), Mount Laurel, NJ - 503B Facility"
   },
   {
    "type": "untitled_letter",
    "date": "2022-04-27",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Untitled Letter 4/27/2022 (PDF - 162KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/163335/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Stokes Healthcare Inc., (dba Epicur Pharma), Mount Laurel, NJ - 503B Facility"
   },
   {
    "type": "483",
    "date": "2020-10-09",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 10/09/2020 (PDF - 603KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/144723/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Stokes Healthcare Inc., (dba Epicur Pharma), Mount Laurel, NJ - 503B Facility"
   }
  ],
  "counts": {
   "form483": 3,
   "warning_letters": 1,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "New Jersey Board of Pharmacy License Verification",
   "url": "https://newjersey.mylicense.com/verification/",
   "kind": "license lookup"
  },
  "state_name": "New Jersey"
 },
 {
  "listed_as": "Tailstorm Health Inc., Chandler, AZ",
  "name": "Tailstorm Health Inc.",
  "city": "Chandler",
  "state": "AZ",
  "phone": "480-274-8617",
  "initial_registration": "10/23/2019",
  "initial_registration_date": "2019-10-23",
  "recent_registration": "10/9/2026",
  "recent_registration_date": "2026-10-09",
  "last_inspection": "8/28/2026",
  "last_inspection_date": "2026-08-28",
  "form483_issued": "Yes",
  "form483_links": [],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "tailstorm-health-inc-chandler-az",
  "aliases": [
   "Tailstorm Health Inc."
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Tailstorm Health, Inc., Chandler, AZ - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   },
   {
    "heading": "Tailstorm Health, Inc., Phoenix, AZ - 503B Facility",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Phoenix, AZ); may be another site of the same company"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "96996",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Phoenix, AZ); may be another site of the same company",
    "recalling_firm": "Tailstorm Health INC",
    "firm_city": "Phoenix",
    "firm_state": "AZ",
    "date": "2025-06-02",
    "report_date": "2025-07-09",
    "classification_date": "2025-06-30",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process."
    ],
    "recall_numbers": [
     "D-0498-2025",
     "D-0499-2025",
     "D-0500-2025",
     "D-0501-2025",
     "D-0502-2025",
     "D-0503-2025"
    ],
    "products": [
     "KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-00",
     "LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Use Only, Compounded Drug by: Medivant Hea",
     "KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2.",
     "BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compou",
     "LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Drug by: Medivant Healthca"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296996%22&limit=100",
    "classification": "Class II",
    "product_count": 6,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "95718",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Phoenix, AZ); may be another site of the same company",
    "recalling_firm": "Tailstorm Health INC",
    "firm_city": "Phoenix",
    "firm_state": "AZ",
    "date": "2024-11-06",
    "report_date": "2024-11-27",
    "classification_date": "2024-11-18",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Sterility Assurance"
    ],
    "recall_numbers": [
     "D-0051-2025"
    ],
    "products": [
     "BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Healthcare: 24416 N 19th Ave, Phoenix, AZ, NDC 81483-0041-1"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2295718%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "recall",
    "event_id": "94930",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "TAILSTORM HEALTH INC",
    "firm_city": "Chandler",
    "firm_state": "AZ",
    "date": "2024-07-03",
    "report_date": "2024-07-17",
    "classification_date": "2024-07-10",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug: reduced efficacy for epinephrine"
    ],
    "recall_numbers": [
     "D-0594-2024"
    ],
    "products": [
     "Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3 81483 00380 2"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2294930%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-08-28",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-08-28",
    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page (\"483 Issued 08/28/2026 (PDF - 9.53MB)\")",
    "url": "https://www.fda.gov/media/195057/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "warning_letter_closeout",
    "date": "2026-03-23",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Phoenix, AZ); may be another site of the same company",
    "text": "Warning Letter Close Out Issued 03/23/2026",
    "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailstorm-health-inc-dba-medivant-health-703497-03232026",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Tailstorm Health, Inc., Phoenix, AZ - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2026-03-20",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Phoenix, AZ); may be another site of the same company",
    "text": "FMD-145 Letter Issued 03/20/2026",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Tailstorm Health, Inc., Phoenix, AZ - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2026-03-19",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Phoenix, AZ); may be another site of the same company",
    "text": "FMD-145 Letter Issued 03/19/2026",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Tailstorm Health, Inc., Phoenix, AZ - 503B Facility"
   },
   {
    "type": "483",
    "date": "2025-11-14",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Phoenix, AZ); may be another site of the same company",
    "text": "483 Issued 11/14/2025",
    "url": "https://www.fda.gov/media/190200/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Tailstorm Health, Inc., Phoenix, AZ - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "96996",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Phoenix, AZ); may be another site of the same company",
    "recalling_firm": "Tailstorm Health INC",
    "firm_city": "Phoenix",
    "firm_state": "AZ",
    "date": "2025-06-02",
    "report_date": "2025-07-09",
    "classification_date": "2025-06-30",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process."
    ],
    "recall_numbers": [
     "D-0498-2025",
     "D-0499-2025",
     "D-0500-2025",
     "D-0501-2025",
     "D-0502-2025",
     "D-0503-2025"
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    "products": [
     "KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-00",
     "LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Use Only, Compounded Drug by: Medivant Hea",
     "KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2.",
     "BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compou",
     "LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Drug by: Medivant Healthca"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296996%22&limit=100",
    "classification": "Class II",
    "product_count": 6,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2025-05-23",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 05/23/2025 (PDF - 1.27 MB)",
    "url": "https://www.fda.gov/media/187975/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Tailstorm Health, Inc., Chandler, AZ - 503B Facility"
   },
   {
    "type": "warning_letter",
    "date": "2025-04-08",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Phoenix, AZ); may be another site of the same company",
    "text": "Warning Letter Issued 04/08/2025",
    "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailstorm-health-inc-dba-medivant-health-703497-04082025",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Tailstorm Health, Inc., Phoenix, AZ - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "95718",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Phoenix, AZ); may be another site of the same company",
    "recalling_firm": "Tailstorm Health INC",
    "firm_city": "Phoenix",
    "firm_state": "AZ",
    "date": "2024-11-06",
    "report_date": "2024-11-27",
    "classification_date": "2024-11-18",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Sterility Assurance"
    ],
    "recall_numbers": [
     "D-0051-2025"
    ],
    "products": [
     "BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Healthcare: 24416 N 19th Ave, Phoenix, AZ, NDC 81483-0041-1"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2295718%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2024-10-10",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Phoenix, AZ); may be another site of the same company",
    "text": "483 Issued 10/10/2024 (PDF - 1.18 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/184179/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Tailstorm Health, Inc., Phoenix, AZ - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "94930",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "TAILSTORM HEALTH INC",
    "firm_city": "Chandler",
    "firm_state": "AZ",
    "date": "2024-07-03",
    "report_date": "2024-07-17",
    "classification_date": "2024-07-10",
    "status": "Ongoing",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Subpotent Drug: reduced efficacy for epinephrine"
    ],
    "recall_numbers": [
     "D-0594-2024"
    ],
    "products": [
     "Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3 81483 00380 2"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2294930%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "fmd145_letter",
    "date": "2023-10-23",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 10/23/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Tailstorm Health, Inc., Chandler, AZ - 503B Facility"
   },
   {
    "type": "untitled_letter",
    "date": "2022-06-17",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Untitled Letter Issued 06/17/2022 (PDF - 404 KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/163521/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Tailstorm Health, Inc., Chandler, AZ - 503B Facility"
   },
   {
    "type": "483",
    "date": "2021-07-21",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 07/21/2021 (PDF - 1 MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/155218/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Tailstorm Health, Inc., Chandler, AZ - 503B Facility"
   }
  ],
  "counts": {
   "form483": 3,
   "warning_letters": 0,
   "recalls": 1,
   "uncertain_items": 8
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Arizona State Board of Pharmacy",
   "url": "https://pharmacy.az.gov/",
   "kind": "board site"
  },
  "state_name": "Arizona"
 },
 {
  "listed_as": "Turbare Manufacturing, Conway, AR",
  "name": "Turbare Manufacturing",
  "city": "Conway",
  "state": "AR",
  "phone": "501-504-6635",
  "initial_registration": "6/23/2023",
  "initial_registration_date": "2023-06-23",
  "recent_registration": "12/3/2025",
  "recent_registration_date": "2025-12-03",
  "last_inspection": "5/7/2026",
  "last_inspection_date": "2026-05-07",
  "form483_issued": "Yes",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "turbare-manufacturing-conway-ar",
  "aliases": [
   "Turbare Manufacturing"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Turbare Manufacturing, Conway, AR - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "96306",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Turbare Manufacturing",
    "firm_city": "Conway",
    "firm_state": "AR",
    "date": "2025-02-18",
    "report_date": "2025-03-05",
    "classification_date": "2025-02-21",
    "status": "Completed",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility: due to a quality control process deviation"
    ],
    "recall_numbers": [
     "D-0248-2025"
    ],
    "products": [
     "Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296306%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-05-07",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-05-07",
    "match": "table",
    "text": "Form FDA 483 issued, per FDA's registration table; document link from FDA's compounding actions page (\"Amended 483 Issued 05/07/2026 (PDF - 2.67 MB)\")",
    "url": "https://www.fda.gov/media/194886/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "warning_letter",
    "date": "2025-09-16",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter (09/16/2025)",
    "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/turbare-manufacturing-713516-09162025",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Turbare Manufacturing, Conway, AR - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "96306",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Turbare Manufacturing",
    "firm_city": "Conway",
    "firm_state": "AR",
    "date": "2025-02-18",
    "report_date": "2025-03-05",
    "classification_date": "2025-02-21",
    "status": "Completed",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility: due to a quality control process deviation"
    ],
    "recall_numbers": [
     "D-0248-2025"
    ],
    "products": [
     "Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, Office Use Only - Not for Resale - Single Use, This drug product was repackaged by Turbare Manufacturing, 925 Jeanette Drive, Conway, AR 72032, NDC: 83556-0101-01."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2296306%22&limit=100",
    "classification": "Class II",
    "product_count": 1,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2025-01-24",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 01/24/2025 (PDF - 1.37MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/185399/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Turbare Manufacturing, Conway, AR - 503B Facility"
   }
  ],
  "counts": {
   "form483": 2,
   "warning_letters": 1,
   "recalls": 1,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Arkansas State Board of Pharmacy",
   "url": "https://www.pharmacyboard.arkansas.gov/",
   "kind": "board site"
  },
  "state_name": "Arkansas"
 },
 {
  "listed_as": "University of Tennessee, Memphis, TN",
  "name": "University of Tennessee",
  "city": "Memphis",
  "state": "TN",
  "phone": "1-901-448-1440",
  "initial_registration": "5/19/2024",
  "initial_registration_date": "2024-05-19",
  "recent_registration": "3/25/2026",
  "recent_registration_date": "2026-03-25",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "university-of-tennessee-memphis-tn",
  "aliases": [
   "University of Tennessee"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Tennessee Department of Health Licensure Verification (Board of Pharmacy)",
   "url": "https://apps.health.tn.gov/Licensure/",
   "kind": "license lookup"
  },
  "state_name": "Tennessee"
 },
 {
  "listed_as": "US Specialty Formulations LLC, Allentown, PA",
  "name": "US Specialty Formulations LLC",
  "city": "Allentown",
  "state": "PA",
  "phone": "610-849-5023",
  "initial_registration": "1/31/2014",
  "initial_registration_date": "2014-01-31",
  "recent_registration": "12/3/2025",
  "recent_registration_date": "2025-12-03",
  "last_inspection": "1/14/2026",
  "last_inspection_date": "2026-01-14",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/183426/download?attachment"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "us-specialty-formulations-llc-allentown-pa",
  "aliases": [
   "US Specialty Formulations LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "US Specialty Formulations LLC, Allentown, PA - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   },
   {
    "heading": "US Specialty Formulations LLC, Bethlehem, PA - 503B Facility",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Bethlehem, PA); may be another site of the same company"
   }
  ],
  "recalls": [
   {
    "type": "recall",
    "event_id": "90257",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "US Specialty Formulations LLC",
    "firm_city": "Allentown",
    "firm_state": "PA",
    "date": "2022-05-24",
    "report_date": "2022-06-15",
    "classification_date": "2022-06-06",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0986-2022",
     "D-0987-2022"
    ],
    "products": [
     "B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%,  Chlorobutanol 0.5%, Riboflavin 0.05%, Chromic Chloride 0.003%), 30 mL Multi-Dose Vial, packaged in 2 x 30 mL Multi-Dose Via",
     "Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA  18103, PN: 69389-06229"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2290257%22&limit=100",
    "classification": "Class II",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-01-14",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/183426/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-01-14",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/183426/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2024-07-02",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 07/02/2024 (PDF - 1.16MB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/183426/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "US Specialty Formulations LLC, Allentown, PA - 503B Facility"
   },
   {
    "type": "warning_letter",
    "date": "2023-07-26",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter (07/26/2023)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/us-specialty-formulations-llc-659142-07262023",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "US Specialty Formulations LLC, Allentown, PA - 503B Facility"
   },
   {
    "type": "recall",
    "event_id": "90257",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "US Specialty Formulations LLC",
    "firm_city": "Allentown",
    "firm_state": "PA",
    "date": "2022-05-24",
    "report_date": "2022-06-15",
    "classification_date": "2022-06-06",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility"
    ],
    "recall_numbers": [
     "D-0986-2022",
     "D-0987-2022"
    ],
    "products": [
     "B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine HCl 2%,  Chlorobutanol 0.5%, Riboflavin 0.05%, Chromic Chloride 0.003%), 30 mL Multi-Dose Vial, packaged in 2 x 30 mL Multi-Dose Via",
     "Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formulations, 1403 South Albert Street, Allentown, PA  18103, PN: 69389-06229"
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2290257%22&limit=100",
    "classification": "Class II",
    "product_count": 2,
    "source": "openFDA drug enforcement API"
   },
   {
    "type": "483",
    "date": "2022-04-26",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Amended 483 Issued 04/26/2022 (PDF - 4.14MB)",
    "url": "https://www.fda.gov/media/160666/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "US Specialty Formulations LLC, Allentown, PA - 503B Facility"
   },
   {
    "type": "483",
    "date": "2019-07-23",
    "match": "uncertain",
    "match_reason": "Name and state match but a different city (Bethlehem, PA); may be another site of the same company",
    "text": "483 Issued 07/23/2019 (PDF - 626KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/131067/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "US Specialty Formulations LLC, Bethlehem, PA - 503B Facility"
   }
  ],
  "counts": {
   "form483": 3,
   "warning_letters": 1,
   "recalls": 1,
   "uncertain_items": 1
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Pennsylvania Licensing System (PALS) Verification (State Board of Pharmacy)",
   "url": "https://www.pals.pa.gov/",
   "kind": "license lookup"
  },
  "state_name": "Pennsylvania"
 },
 {
  "listed_as": "Vitae Enim Vitae Scientific, Inc., San Diego, CA",
  "name": "Vitae Enim Vitae Scientific, Inc.",
  "city": "San Diego",
  "state": "CA",
  "phone": "858-222-0746",
  "initial_registration": "1/2/2024",
  "initial_registration_date": "2024-01-02",
  "recent_registration": "12/29/2025",
  "recent_registration_date": "2025-12-29",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "No",
  "slug": "vitae-enim-vitae-scientific-inc-san-diego-ca",
  "aliases": [
   "Vitae Enim Vitae Scientific, Inc."
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [
   {
    "type": "recall",
    "event_id": "89803",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Vitae Enim Vitae Scientific, Inc.",
    "firm_city": "San Diego",
    "firm_state": "CA",
    "date": "2022-03-14",
    "report_date": "2022-04-13",
    "classification_date": "2022-04-05",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile."
    ],
    "recall_numbers": [
     "D-0741-2022",
     "D-0742-2022",
     "D-0743-2022",
     "D-0744-2022"
    ],
    "products": [
     "TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pharmaceuticals, LLC., NDC 42494-437-10.",
     "PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL Vials per box (NDC 42494-415-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC.",
     "PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-416-25) and b) 3 x 1mL Vials per box (NDC 42494-416-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC.",
     "PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b) 10 x 2mL Single Use Vials per box (NDC 72516-024-10); Manufactured for Oryza Pharmaceuticals, Inc."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2289803%22&limit=100",
    "classification": "Class II",
    "product_count": 4,
    "source": "openFDA drug enforcement API"
   }
  ],
  "timeline": [
   {
    "type": "recall",
    "event_id": "89803",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "recalling_firm": "Vitae Enim Vitae Scientific, Inc.",
    "firm_city": "San Diego",
    "firm_state": "CA",
    "date": "2022-03-14",
    "report_date": "2022-04-13",
    "classification_date": "2022-04-05",
    "status": "Terminated",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "reasons": [
     "Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile."
    ],
    "recall_numbers": [
     "D-0741-2022",
     "D-0742-2022",
     "D-0743-2022",
     "D-0744-2022"
    ],
    "products": [
     "TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pharmaceuticals, LLC., NDC 42494-437-10.",
     "PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL Vials per box (NDC 42494-415-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC.",
     "PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-416-25) and b) 3 x 1mL Vials per box (NDC 42494-416-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC.",
     "PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b) 10 x 2mL Single Use Vials per box (NDC 72516-024-10); Manufactured for Oryza Pharmaceuticals, Inc."
    ],
    "url": "https://api.fda.gov/drug/enforcement.json?search=event_id:%2289803%22&limit=100",
    "classification": "Class II",
    "product_count": 4,
    "source": "openFDA drug enforcement API"
   }
  ],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 1,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "California State Board of Pharmacy (DCA License Search)",
   "url": "https://search.dca.ca.gov/",
   "kind": "license lookup"
  },
  "state_name": "California"
 },
 {
  "listed_as": "VitalRx Pharmacy, LLC, Houston, TX",
  "name": "VitalRx Pharmacy, LLC",
  "city": "Houston",
  "state": "TX",
  "phone": "1-832-259-1362",
  "initial_registration": "8/27/2024",
  "initial_registration_date": "2024-08-27",
  "recent_registration": "1/3/2026",
  "recent_registration_date": "2026-01-03",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "vitalrx-pharmacy-llc-houston-tx",
  "aliases": [
   "VitalRx Pharmacy, LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Texas State Board of Pharmacy License Verification",
   "url": "https://www.pharmacy.texas.gov/dbsearch/phy_search.asp",
   "kind": "license lookup"
  },
  "state_name": "Texas"
 },
 {
  "listed_as": "Wedgewood Connect, LLC, formerly registered as Leiter's Compounding, San Jose, CA",
  "name": "Wedgewood Connect, LLC, formerly registered as Leiter's Compounding",
  "city": "San Jose",
  "state": "CA",
  "phone": "669-297-0857",
  "initial_registration": "1/31/2014",
  "initial_registration_date": "2014-01-31",
  "recent_registration": "11/25/2025",
  "recent_registration_date": "2025-11-25",
  "last_inspection": "7/3/2025",
  "last_inspection_date": "2025-07-03",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/188152/download?attachment"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "wedgewood-connect-llc-formerly-registered-as-leiter-s-compounding-san-jose-ca",
  "aliases": [
   "Wedgewood Connect, LLC",
   "Leiter's Compounding"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Wedgewood Connect, LLC, San Jose, CA - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "fmd145_letter",
    "date": "2026-01-02",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 01/02/2026",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Wedgewood Connect, LLC, San Jose, CA - 503B Facility"
   },
   {
    "type": "inspection",
    "date": "2025-07-03",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/188152/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2025-07-03",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/188152/download?attachment",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "fmd145_letter",
    "date": "2024-09-17",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 09/17/2024",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Wedgewood Connect, LLC, San Jose, CA - 503B Facility"
   },
   {
    "type": "untitled_letter",
    "date": "2024-04-25",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Untitled Letter Issued 04/25/2024 (PDF - 536KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/178598/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Wedgewood Connect, LLC, San Jose, CA - 503B Facility"
   },
   {
    "type": "483",
    "date": "2023-11-17",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 11/17/2023 (PDF - 1.97MB)",
    "url": "https://www.fda.gov/media/176195/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Wedgewood Connect, LLC, San Jose, CA - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2022-04-28",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 04/28/2022",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Wedgewood Connect, LLC, San Jose, CA - 503B Facility"
   },
   {
    "type": "483",
    "date": "2021-12-03",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Amended 483 Issued 12/03/2021 (PDF - 898KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/157736/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Wedgewood Connect, LLC, San Jose, CA - 503B Facility"
   }
  ],
  "counts": {
   "form483": 3,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "California State Board of Pharmacy (DCA License Search)",
   "url": "https://search.dca.ca.gov/",
   "kind": "license lookup"
  },
  "state_name": "California"
 },
 {
  "listed_as": "Wedgewood Connect Ohio, LLC, Albany, OH",
  "name": "Wedgewood Connect Ohio, LLC",
  "city": "Albany",
  "state": "OH",
  "phone": "1-859-893-4935",
  "initial_registration": "10/19/2023",
  "initial_registration_date": "2023-10-19",
  "recent_registration": "12/16/2025",
  "recent_registration_date": "2025-12-16",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "wedgewood-connect-ohio-llc-albany-oh",
  "aliases": [
   "Wedgewood Connect Ohio, LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Ohio eLicense Verification (Board of Pharmacy)",
   "url": "https://elicense.ohio.gov/oh_verifylicense",
   "kind": "license lookup"
  },
  "state_name": "Ohio"
 },
 {
  "listed_as": "Wells Pharma of Houston, LLC, Houston, TX",
  "name": "Wells Pharma of Houston, LLC",
  "city": "Houston",
  "state": "TX",
  "phone": "1-346-888-1010",
  "initial_registration": "3/9/2020",
  "initial_registration_date": "2020-03-09",
  "recent_registration": "12/3/2025",
  "recent_registration_date": "2025-12-03",
  "last_inspection": "4/13/2026",
  "last_inspection_date": "2026-04-13",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/192443/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "wells-pharma-of-houston-llc-houston-tx",
  "aliases": [
   "Wells Pharma of Houston, LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [
   {
    "heading": "Wells Pharma of Houston LLC, Houston, TX - 503B Facility",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match"
   }
  ],
  "recalls": [],
  "timeline": [
   {
    "type": "483",
    "date": "2026-04-14",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Amended 483 Issued 04/14/2026 (PDF - 1.44 MB)",
    "url": "https://www.fda.gov/media/192443/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Wells Pharma of Houston LLC, Houston, TX - 503B Facility"
   },
   {
    "type": "inspection",
    "date": "2026-04-13",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/192443/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-04-13",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/192443/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "warning_letter",
    "date": "2025-11-07",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "Warning Letter Issued 11/07/2025",
    "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wells-pharma-houston-llc-713015-11072025",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Wells Pharma of Houston LLC, Houston, TX - 503B Facility"
   },
   {
    "type": "483",
    "date": "2025-03-28",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 issued 03/28/2025 (PDF - 2.72MB)",
    "url": "https://www.fda.gov/media/186290/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Wells Pharma of Houston LLC, Houston, TX - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2023-04-18",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 4/18/2023",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Wells Pharma of Houston LLC, Houston, TX - 503B Facility"
   },
   {
    "type": "483",
    "date": "2022-12-14",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 12/14/2022 (PDF - 611KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/165151/download",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Wells Pharma of Houston LLC, Houston, TX - 503B Facility"
   },
   {
    "type": "fmd145_letter",
    "date": "2022-01-10",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "FMD-145 Letter Issued 01/10/2022",
    "url": null,
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Wells Pharma of Houston LLC, Houston, TX - 503B Facility"
   },
   {
    "type": "483",
    "date": "2021-06-17",
    "match": "confirmed",
    "match_reason": "Exact name, city and state match",
    "text": "483 Issued 06/17/2021 (PDF - 240KB)",
    "url": "https://web.archive.org/web/20250506103522/https://www.fda.gov/media/155873/download?attachment",
    "source": "FDA Compounding: Inspections, Recalls, and other Actions",
    "listed_under": "Wells Pharma of Houston LLC, Houston, TX - 503B Facility"
   }
  ],
  "counts": {
   "form483": 5,
   "warning_letters": 1,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": true,
  "board": {
   "name": "Texas State Board of Pharmacy License Verification",
   "url": "https://www.pharmacy.texas.gov/dbsearch/phy_search.asp",
   "kind": "license lookup"
  },
  "state_name": "Texas"
 },
 {
  "listed_as": "Wells Pharmacy, Inc., Dyersburg, TN",
  "name": "Wells Pharmacy, Inc.",
  "city": "Dyersburg",
  "state": "TN",
  "phone": "800-622-4510",
  "initial_registration": "6/7/2016",
  "initial_registration_date": "2016-06-07",
  "recent_registration": "11/28/2025",
  "recent_registration_date": "2025-11-28",
  "last_inspection": "4/9/2026",
  "last_inspection_date": "2026-04-09",
  "form483_issued": "Yes",
  "form483_links": [
   {
    "text": "Yes",
    "url": "https://www.fda.gov/media/192260/download"
   }
  ],
  "recall_conducted": "No",
  "action_last_inspection": "Open",
  "action_links": [],
  "prior_history_footnote": true,
  "sterile_from_bulk": "Yes",
  "slug": "wells-pharmacy-inc-dyersburg-tn",
  "aliases": [
   "Wells Pharmacy, Inc."
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [
   {
    "type": "inspection",
    "date": "2026-04-09",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: Yes",
    "url": "https://www.fda.gov/media/192260/download",
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "483",
    "date": "2026-04-09",
    "match": "table",
    "text": "Form FDA 483 (linked from FDA's registration table)",
    "url": "https://www.fda.gov/media/192260/download",
    "source": "FDA registered outsourcing facilities table"
   }
  ],
  "counts": {
   "form483": 1,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Tennessee Department of Health Licensure Verification (Board of Pharmacy)",
   "url": "https://apps.health.tn.gov/Licensure/",
   "kind": "license lookup"
  },
  "state_name": "Tennessee"
 },
 {
  "listed_as": "White Label Pharmacy dba Nova Pharmacy, Katy, TX",
  "name": "White Label Pharmacy dba Nova Pharmacy",
  "city": "Katy",
  "state": "TX",
  "phone": "833-789-3305",
  "initial_registration": "12/16/2025",
  "initial_registration_date": "2025-12-16",
  "recent_registration": "12/16/2025",
  "recent_registration_date": "2025-12-16",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "white-label-pharmacy-dba-nova-pharmacy-katy-tx",
  "aliases": [
   "White Label Pharmacy",
   "Nova Pharmacy"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Texas State Board of Pharmacy License Verification",
   "url": "https://www.pharmacy.texas.gov/dbsearch/phy_search.asp",
   "kind": "license lookup"
  },
  "state_name": "Texas"
 },
 {
  "listed_as": "Wesley Pharmaceuticals, Orlando, FL",
  "name": "Wesley Pharmaceuticals",
  "city": "Orlando",
  "state": "FL",
  "phone": "1-407-440-1555",
  "initial_registration": "7/25/2025",
  "initial_registration_date": "2025-07-25",
  "recent_registration": "11/22/2025",
  "recent_registration_date": "2025-11-22",
  "last_inspection": "3/16/2026",
  "last_inspection_date": "2026-03-16",
  "form483_issued": "No",
  "form483_links": [],
  "recall_conducted": "No",
  "action_last_inspection": "FMD-145 Letter Issued 6/17/2026",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "wesley-pharmaceuticals-orlando-fl",
  "aliases": [
   "Wesley Pharmaceuticals"
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  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [
   {
    "type": "fmd145_letter",
    "date": "2026-06-17",
    "match": "table",
    "text": "FMD-145 Letter Issued 6/17/2026",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   },
   {
    "type": "inspection",
    "date": "2026-03-16",
    "match": "table",
    "text": "Last inspection per FDA table; Form 483 issued: No",
    "url": null,
    "source": "FDA registered outsourcing facilities table"
   }
  ],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Florida Department of Health License Verification (Board of Pharmacy)",
   "url": "https://mqa-internet.doh.state.fl.us/MQASearchServices/Home",
   "kind": "license lookup"
  },
  "state_name": "Florida"
 },
 {
  "listed_as": "Wilcrest Pharmaceuticals, Inc., Houston, TX",
  "name": "Wilcrest Pharmaceuticals, Inc.",
  "city": "Houston",
  "state": "TX",
  "phone": "1-713-277-4114",
  "initial_registration": "3/13/2025",
  "initial_registration_date": "2025-03-13",
  "recent_registration": "12/2/2025",
  "recent_registration_date": "2025-12-02",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "wilcrest-pharmaceuticals-inc-houston-tx",
  "aliases": [
   "Wilcrest Pharmaceuticals, Inc."
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  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Texas State Board of Pharmacy License Verification",
   "url": "https://www.pharmacy.texas.gov/dbsearch/phy_search.asp",
   "kind": "license lookup"
  },
  "state_name": "Texas"
 },
 {
  "listed_as": "Willowbend Pharma Select, LLC, Houston, TX",
  "name": "Willowbend Pharma Select, LLC",
  "city": "Houston",
  "state": "TX",
  "phone": "832-628-3260",
  "initial_registration": "4/11/2024",
  "initial_registration_date": "2024-04-11",
  "recent_registration": "12/12/2025",
  "recent_registration_date": "2025-12-12",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "willowbend-pharma-select-llc-houston-tx",
  "aliases": [
   "Willowbend Pharma Select, LLC"
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "Texas State Board of Pharmacy License Verification",
   "url": "https://www.pharmacy.texas.gov/dbsearch/phy_search.asp",
   "kind": "license lookup"
  },
  "state_name": "Texas"
 },
 {
  "listed_as": "Xseer Pharmaceuticals, Inc., Los Angeles, CA",
  "name": "Xseer Pharmaceuticals, Inc.",
  "city": "Los Angeles",
  "state": "CA",
  "phone": "310-606-0146",
  "initial_registration": "10/21/2023",
  "initial_registration_date": "2023-10-21",
  "recent_registration": "12/25/2025",
  "recent_registration_date": "2025-12-25",
  "last_inspection": "Not yet inspected",
  "last_inspection_date": null,
  "form483_issued": "N/A",
  "form483_links": [],
  "recall_conducted": "N/A",
  "action_last_inspection": "N/A",
  "action_links": [],
  "prior_history_footnote": false,
  "sterile_from_bulk": "Yes",
  "slug": "xseer-pharmaceuticals-inc-los-angeles-ca",
  "aliases": [
   "Xseer Pharmaceuticals, Inc."
  ],
  "data_notes": [],
  "actions_page_entries": [],
  "recalls": [],
  "timeline": [],
  "counts": {
   "form483": 0,
   "warning_letters": 0,
   "recalls": 0,
   "uncertain_items": 0
  },
  "recent_wl_or_recall": false,
  "board": {
   "name": "California State Board of Pharmacy (DCA License Search)",
   "url": "https://search.dca.ca.gov/",
   "kind": "license lookup"
  },
  "state_name": "California"
 }
]