{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA078591"
        ],
        "brand_name": [
          "HYDROMORPHONE HYDROCHLORIDE"
        ],
        "generic_name": [
          "HYDROMORPHONE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "0409-2634"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "HYDROMORPHONE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1724338",
          "1724340",
          "1724341"
        ],
        "spl_id": [
          "f0c8c83c-fb41-4571-a72e-6542311351dd"
        ],
        "spl_set_id": [
          "3832ede8-d3fc-455d-ecab-3b77be5869f5"
        ],
        "package_ndc": [
          "0409-2634-10",
          "0409-2634-01",
          "0409-2634-25",
          "0409-2634-05",
          "0409-2634-50"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "L960UP2KRW"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79114",
      "recalling_firm": "Pfizer Inc.",
      "address_1": "235 E 42nd St",
      "address_2": "",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0597-2018",
      "product_description": "Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation.  Hospira, Inc., Lake forest, IL 60045 USA.  NDC:  0409-2634-01",
      "product_quantity": "29, 680 vials",
      "reason_for_recall": "Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.",
      "recall_initiation_date": "20180207",
      "center_classification_date": "20180314",
      "termination_date": "20190807",
      "report_date": "20180321",
      "code_info": "Lot 71330DD EXP. 11/1/2018.",
      "more_code_info": ""
    }
  ]
}