{
  "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": "2026-07-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Lake Forest",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA074802"
        ],
        "brand_name": [
          "KETOROLAC TROMETHAMINE"
        ],
        "generic_name": [
          "KETOROLAC TROMETHAMINE"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "0409-3793",
          "0409-3795",
          "0409-3796"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "KETOROLAC TROMETHAMINE"
        ],
        "rxcui": [
          "860092",
          "1665459",
          "1665461"
        ],
        "spl_id": [
          "572e3ce2-a27c-4a65-9593-84666518ddca"
        ],
        "spl_set_id": [
          "8accbb78-fc64-45d5-69b0-35c23a1d2a2e"
        ],
        "package_ndc": [
          "0409-3793-19",
          "0409-3793-01",
          "0409-3793-25",
          "0409-3795-19",
          "0409-3795-01",
          "0409-3795-25",
          "0409-3796-19",
          "0409-3796-01",
          "0409-3796-25"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4EVE5946BQ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "66050",
      "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": "Naitonwide",
      "recall_number": "D-926-2013",
      "product_description": "Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA,  NDC 0409-3795-01",
      "product_quantity": "345,800 vials",
      "reason_for_recall": "Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials.",
      "recall_initiation_date": "20130812",
      "center_classification_date": "20130828",
      "termination_date": "20141028",
      "report_date": "20130904",
      "code_info": "Lot  25048DK  Exp. 01/15",
      "more_code_info": ""
    }
  ]
}