{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Lake Forest",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA070914"
        ],
        "brand_name": [
          "NALBUPHINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "NALBUPHINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "0409-1463",
          "0409-1465",
          "0409-1464",
          "0409-1467"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "NALBUPHINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "904415",
          "904440",
          "1866543",
          "1866551"
        ],
        "spl_id": [
          "cbcbf107-67c0-4a8a-a25d-5a05c43a0bfd"
        ],
        "spl_set_id": [
          "6025e8d4-5083-4c3a-58a0-050e7b0b6150"
        ],
        "package_ndc": [
          "0409-1463-71",
          "0409-1463-01",
          "0409-1465-71",
          "0409-1465-01",
          "0409-1464-61",
          "0409-1464-01",
          "0409-1467-61",
          "0409-1467-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "ZU4275277R"
        ]
      },
      "product_type": "Drugs",
      "event_id": "63884",
      "recalling_firm": "Hospira, Inc.",
      "address_1": "600 N Field Dr Bldg J45",
      "address_2": "",
      "postal_code": "60045",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico.",
      "recall_number": "D-096-2013",
      "product_description": "Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1467-01",
      "product_quantity": "145,400 vials",
      "reason_for_recall": "Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.",
      "recall_initiation_date": "20121121",
      "center_classification_date": "20121220",
      "termination_date": "20140603",
      "report_date": "20121226",
      "code_info": "Lot #: 11-293-DK, Exp 05/01/13",
      "more_code_info": ""
    }
  ]
}