{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Bridgewater",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA008372"
        ],
        "brand_name": [
          "ACTHAR"
        ],
        "generic_name": [
          "REPOSITORY CORTICOTROPIN"
        ],
        "manufacturer_name": [
          "Mallinckrodt ARD LLC"
        ],
        "product_ndc": [
          "63004-8710",
          "63004-8712",
          "63004-8711"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "CORTICOTROPIN"
        ],
        "rxcui": [
          "309541",
          "1040025",
          "2685293",
          "2685296",
          "2685298",
          "2685299"
        ],
        "spl_id": [
          "c63a790c-ec8a-4037-bbd3-cfe75cdd81ab"
        ],
        "spl_set_id": [
          "7b48ddec-e815-45f4-9ca0-5c0daaf56f30"
        ],
        "package_ndc": [
          "63004-8710-1",
          "63004-8710-2",
          "63004-8712-1",
          "63004-8712-4",
          "63004-8711-1",
          "63004-8711-4"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363004871213"
        ],
        "nui": [
          "M0000499",
          "N0000175941"
        ],
        "pharm_class_cs": [
          "Adrenocorticotropic Hormone [CS]"
        ],
        "pharm_class_epc": [
          "Adrenocorticotropic Hormone [EPC]"
        ],
        "unii": [
          "K0U68Q2TXA"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99570",
      "recalling_firm": "Mallinckrodt Hospital Products Inc.",
      "address_1": "440 Us Highway 22 Ste 302",
      "address_2": "N/A",
      "postal_code": "08807-2477",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0803-2026",
      "product_description": "Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2",
      "product_quantity": "12367 vials",
      "reason_for_recall": "Presence of particulate matter: glass and stopper piece",
      "recall_initiation_date": "20260806",
      "center_classification_date": "20260826",
      "report_date": "20260902",
      "code_info": "Lot#:  NDC 63004-8710-1 - 1564-107, exp 1/31/2027  NDC 63004-8710-2 - 1564-107H, exp 1/31/2027"
    }
  ]
}