{
  "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 II",
      "openfda": {
        "application_number": [
          "NDA200403"
        ],
        "brand_name": [
          "HYDROMORPHONE HYDROCHLORIDE"
        ],
        "generic_name": [
          "HYDROMORPHONE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "0409-1283",
          "0409-2552",
          "0409-3356",
          "0409-2540",
          "0409-3365",
          "0409-1312",
          "0409-1304"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "HYDROMORPHONE HYDROCHLORIDE"
        ],
        "rxcui": [
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          "897753",
          "897756",
          "897757",
          "897758",
          "1724276",
          "1724383",
          "1724644"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
          "0409-2552-11",
          "0409-2552-01",
          "0409-3356-11",
          "0409-3356-01",
          "0409-2540-11",
          "0409-2540-01",
          "0409-3365-11",
          "0409-3365-01",
          "0409-3365-10",
          "0409-1283-03",
          "0409-1283-31",
          "0409-1312-03",
          "0409-1312-30",
          "0409-1304-03",
          "0409-1304-31"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "L960UP2KRW"
        ]
      },
      "product_type": "Drugs",
      "event_id": "77956",
      "recalling_firm": "Pfizer Inc.",
      "address_1": "235 E 42nd St",
      "address_2": "N/A",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "United States Nationwide (including Puerto Rico) and Singapore",
      "recall_number": "D-1167-2017",
      "product_description": "HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial)",
      "product_quantity": "115,370 vials",
      "reason_for_recall": "Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.",
      "recall_initiation_date": "20170822",
      "center_classification_date": "20170915",
      "termination_date": "20230219",
      "report_date": "20170927",
      "code_info": "Lot: 760853A",
      "more_code_info": ""
    }
  ]
}