{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "West Columbia",
      "state": "SC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA211445"
        ],
        "brand_name": [
          "KETOROLAC TROMETHAMINE"
        ],
        "generic_name": [
          "KETOROLAC TROMETHAMINE"
        ],
        "manufacturer_name": [
          "Nephron Pharmaceuticals Corporation"
        ],
        "product_ndc": [
          "0487-6232"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "substance_name": [
          "KETOROLAC TROMETHAMINE"
        ],
        "rxcui": [
          "1665459"
        ],
        "spl_id": [
          "47e5aabd-6afa-7c55-e063-6394a90a2e81"
        ],
        "spl_set_id": [
          "ae6c60c0-e88a-45b2-e053-2995a90ac62f"
        ],
        "package_ndc": [
          "0487-6232-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "4EVE5946BQ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90703",
      "recalling_firm": "Nephron Sc Inc",
      "address_1": "4500 12th Street Ext",
      "address_2": "",
      "postal_code": "29172-3025",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-1354-2022",
      "product_description": "Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01",
      "product_quantity": "5040 vials",
      "reason_for_recall": "cGMP Deviations: deviations leading to potential cross-contamination.",
      "recall_initiation_date": "20220810",
      "center_classification_date": "20220817",
      "termination_date": "20240924",
      "report_date": "20220824",
      "code_info": "Lot#: 023011 Exp 8/31/2022",
      "more_code_info": ""
    }
  ]
}