{
  "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": "Schaumburg",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA204216"
        ],
        "brand_name": [
          "KETOROLAC TROMETHAMINE"
        ],
        "generic_name": [
          "KETOROLAC TROMETHAMINE"
        ],
        "manufacturer_name": [
          "Sagent Pharmaceuticals"
        ],
        "product_ndc": [
          "25021-700",
          "25021-701"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "KETOROLAC TROMETHAMINE"
        ],
        "rxcui": [
          "860092",
          "1665459",
          "1665461"
        ],
        "spl_id": [
          "cb23332a-48fa-458b-93ab-c4eef189a051"
        ],
        "spl_set_id": [
          "62591551-a644-4b2c-a0de-982e906fabc3"
        ],
        "package_ndc": [
          "25021-700-01",
          "25021-701-01",
          "25021-701-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4EVE5946BQ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "69485",
      "recalling_firm": "Sagent Pharmaceuticals Inc",
      "address_1": "1901 N Roselle Rd Ste 700",
      "address_2": "N/A",
      "postal_code": "60195-3194",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-0027-2015",
      "product_description": "Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195",
      "product_quantity": "69,050 vials",
      "reason_for_recall": "Incorrect or Missing Lot and/or Exp Date:  Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.",
      "recall_initiation_date": "20141003",
      "center_classification_date": "20141016",
      "termination_date": "20160223",
      "report_date": "20141022",
      "code_info": "Lot MP5021, Exp. 04/16; Lots MP5024, MP5025, Exp. 05/16"
    }
  ]
}