{
  "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": "Ongoing",
      "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": "71681",
      "recalling_firm": "Hospira Inc.",
      "address_1": "600 N Field Dr",
      "address_2": "N/A",
      "postal_code": "60045-4835",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide, Puerto Rico, Guam, Canada and Singapore",
      "recall_number": "D-1241-2015",
      "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": "12,460,975 vials(Hospira label); 3,016,500 vials (NOVAPLUS label)",
      "reason_for_recall": "Crystallization; identified as calcium salt of Ketorolac",
      "recall_initiation_date": "20150630",
      "center_classification_date": "20150715",
      "report_date": "20150722",
      "code_info": "31077DK, 31078DK, 31338DK, 31339DK, 31340DK, EXP 01JUL2015; 32068DK, 32069DK, EXP 01AUG2915; 33270DK, EXP 01SEP2015; 34084DK, 34085DK, 34161DK, 34162DK, 34298DK, 34299DK, 34300DK, EXP 01OCT2015; 35011DK, 35081DK, 35082DK, 35116DK, EXP 01NOV2015; 38139DK, 38140DK, 36144DK, EXP 01FEB2016; 39256DK, 39257DK, EXP 01MAR2016; 42210DK, 42227DK, EXP01JUN2016; 43017DK, 43116DK, 43117DK, 43292DK, 43293DK, EXP 01JUL2016; 45034DK, 45035DK, 45118DK, 45120DK, EXP 01SEP2016; 46310DK, 46311DK, EXP 01OCT2016 AND NOVAPLUS LOTS 32106DK, 32220DK, 32221DK, EXP 01AUG2015; 33235DK, 33236DK, EXP 01SEP2015; 34163DK, 34164DK, EXP 01OCT2015; 39263DK, 39264DK, EXP 01MAR2016",
      "more_code_info": ""
    }
  ]
}