{
  "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": [
          "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": [
          "39818912-fe5a-4c06-8148-13bf1884e0ca"
        ],
        "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",
          "0409-3796-49"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4EVE5946BQ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "70515",
      "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": "Letter",
      "distribution_pattern": "U.S. Nationwide and International: Guam and Singapore.",
      "recall_number": "D-0483-2015",
      "product_description": "KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49",
      "product_quantity": "HOSPIRA = 4,339,500 vials. NOVAPLUS = 341,100 vials",
      "reason_for_recall": "Crystallization",
      "recall_initiation_date": "20150123",
      "center_classification_date": "20150408",
      "termination_date": "20160204",
      "report_date": "20150415",
      "code_info": "NDC 0409-3796-01,   Lot number: 26-098-DK, Exp. Date:1FEB2015;   Lot number: 29-239-DK, 29-240-DK, Exp. Date:1MAY2015;   Lot number: 34-540-DK, Exp. Date:1OCT2015;  Lot number: 37-037-DK, 37-038-DK, 37-147-DK, 37-148-DK, 37-228-DK, 37-282-DK, Exp. Date:1JAN2016;   Lot number: 41-282-DK, 41-284-DK, Exp. Date:1MAY2016;   Lot number: 44-076-DK, Exp. Date:1AUG2016;   Lot number: 45-240-DK, Exp. Date:1SEP2016 and   Lot number: 46-306-DK, Exp. Date:1OCT2016 AND NOVAPLUS label    NDC 0409-3796-49,   Lot number: 26-097-DK, Exp. Date:1FEB2015."
    }
  ]
}