{
  "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": "Terminated",
      "city": "Melrose Park",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA204223"
        ],
        "brand_name": [
          "MORPHINE SULFATE"
        ],
        "generic_name": [
          "MORPHINE SULFATE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-451",
          "63323-452",
          "63323-454",
          "63323-455",
          "63323-458"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "MORPHINE SULFATE"
        ],
        "rxcui": [
          "1731993",
          "1732006",
          "1732011",
          "1732136",
          "2003714"
        ],
        "spl_id": [
          "dbf870e7-7bfe-48f0-ba6a-9cc476dfe5cc"
        ],
        "spl_set_id": [
          "582f42e5-444e-4246-af8c-e7e28097c69a"
        ],
        "package_ndc": [
          "63323-452-00",
          "63323-452-01",
          "63323-454-00",
          "63323-454-01",
          "63323-455-00",
          "63323-455-01",
          "63323-458-00",
          "63323-458-01",
          "63323-451-00",
          "63323-451-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363323454005",
          "0363323451004"
        ],
        "unii": [
          "X3P646A2J0"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88698",
      "recalling_firm": "Fresenius Kabi USA LLC",
      "address_1": "2020 N Ruby St",
      "address_2": "N/A",
      "postal_code": "60160-1112",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.A. Nationwide",
      "recall_number": "D-0856-2021",
      "product_description": "Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01.  25 vials per tray packaged 18 trays per shipper",
      "product_quantity": "963000 vials",
      "reason_for_recall": "Defective container: Cracked vials leading to lack of sterility assurance",
      "recall_initiation_date": "20210917",
      "center_classification_date": "20210927",
      "termination_date": "20230620",
      "report_date": "20211006",
      "code_info": "Lot #  6023731, 6023732, Exp 03/2023; 6024172, 6024260, Exp 06/2023"
    }
  ]
}