{
  "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",
          "0409-3795-49"
        ],
        "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-0482-2015",
      "product_description": "KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49",
      "product_quantity": "HOSPIRA = 13,720,475 vials, NOVAPLUS = 1,528,500 vials",
      "reason_for_recall": "Crystallization",
      "recall_initiation_date": "20150123",
      "center_classification_date": "20150408",
      "termination_date": "20160204",
      "report_date": "20150415",
      "code_info": "NDC 0409-3795-01,   Lot number: 25-047-DK, 25-048-DK, Exp 1JAN2015;   Lot number 26-151-DK, Exp. Date:1FEB2015;   Lot number: 28-059-DK, 28-071-DK, 28-072-DK, 28-479-DK, 28-480-DK, Exp. Date:1APR2015;   Lot number: 29-556-DK, 29-557-DK, Exp. Date:1MAY2015;   Lot number: 35-232-DK, 35-233-DK, 35-234-DK, 35-501-DK, Exp. Date:1NOV2015;   Lot number: 36-341-DK, 36-342-DK, 36-343-DK, 36-353-DK, 36-429-DK, 36-430-DK, Exp. Date:1DEC2015;   Lot number: 37-141-DK, 37-142-DK, 37-144-DK, 37-145-DK, 37-353-DK, Exp. Date:1JAN2016;   Lot number: 38-141-DK, 38-143-DK, Exp. Date:1FEB2016;   Lot number: 39-014-DK, 39-104-DK, Exp. Date:1MAR2016;   Lot number: 40-301-DK, 40-536-DK, 40-537-DK, 40-544-DK, 40-548-DK, Exp. Date:1APR2016;   Lot number: 41-078-DK, Exp. Date:1MAY2016;   Lot number: 42-207-DK, 42-253-DK, Exp. Date:1JUN2016;   Lot number: 45-358-DK, 45-359-DK, Exp. Date:1SEP2016;   Lot number: 46-043-DK, 46-044-DK, 46-047-DK, Exp. Date:1OCT2016    AND NOVAPLUS LABEL   NDC 0409-3795-49,   Lot number: 27-101-DK, Exp. Date:1MAR2015;   Lot number: 35-229-DK, Exp. Date:1NOV2015;   Lot number: 36-217-DK, 36-218-DK, Exp. Date:1DEC2015 and   Lot number: 40-534-DK, Exp. Date:1APR2016"
    }
  ]
}