{
  "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": [
          "ANDA074137"
        ],
        "brand_name": [
          "BUPRENORPHINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "BUPRENORPHINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "0409-2012"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "BUPRENORPHINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1655032"
        ],
        "spl_id": [
          "37d2deb6-c54a-42bb-ad76-4873a59da562"
        ],
        "spl_set_id": [
          "23aa1bb3-cecf-4e62-29bb-48488bb66fc3"
        ],
        "package_ndc": [
          "0409-2012-03",
          "0409-2012-32"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "56W8MW3EN1"
        ]
      },
      "product_type": "Drugs",
      "event_id": "69163",
      "recalling_firm": "Hospira Inc.",
      "address_1": "275 N Field Dr",
      "address_2": "N/A",
      "postal_code": "60045-2579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1604-2014",
      "product_description": "Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10  Carpuject Sterile Cartridge Units with Luer Lock, Slim-Paks, F Intramuscular or Intravenous Use, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2012-32",
      "product_quantity": "373,180 Carpuject units",
      "reason_for_recall": "Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.",
      "recall_initiation_date": "20140909",
      "center_classification_date": "20140919",
      "termination_date": "20170317",
      "report_date": "20141001",
      "code_info": "Lot Number:  35-730-LL, 35-745-LL, Exp:  1 FEB 2015"
    }
  ]
}