{
  "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": "LAKE FOREST",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "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": "77836",
      "recalling_firm": "HOSPIRA INC, LAKE FOREST",
      "address_1": "275 NORTH FOREST DRIVE",
      "address_2": "N/A",
      "postal_code": "60045",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-1081-2017",
      "product_description": "Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc., Lake Forest, IL 60045 USA, NDC: 0409-2634-50",
      "product_quantity": "9,009 vials",
      "reason_for_recall": "Presence of Particulate Matter: Silicone oil",
      "recall_initiation_date": "20170726",
      "center_classification_date": "20170809",
      "termination_date": "20180511",
      "report_date": "20170816",
      "code_info": "Lot #: 56260DD, Exp. 01AUG2017"
    }
  ]
}