{
  "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": "2026-07-22",
    "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"
        ],
        "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": "93945",
      "recalling_firm": "Mallinckrodt Hospital Products Inc.",
      "address_1": "440 Us Highway 22",
      "address_2": "Ste 302",
      "postal_code": "08807-2477",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA nationwide",
      "recall_number": "D-0340-2024",
      "product_description": "Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1",
      "product_quantity": "8 vials involved in recall (16,479 vials distributed)",
      "reason_for_recall": "cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.",
      "recall_initiation_date": "20240206",
      "center_classification_date": "20240221",
      "report_date": "20240228",
      "code_info": "Lot #: 1564-103, Exp 9/30/2024"
    }
  ]
}