{
  "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 Zurich",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA091596"
        ],
        "brand_name": [
          "TRANEXAMIC ACID"
        ],
        "generic_name": [
          "TRANEXAMIC ACID"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-563"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "TRANEXAMIC ACID"
        ],
        "rxcui": [
          "238720"
        ],
        "spl_id": [
          "ddb5d068-9d9e-45da-92d7-516dd792af1b"
        ],
        "spl_set_id": [
          "c6c3da51-fc45-4d5c-b983-1576830c95dd"
        ],
        "package_ndc": [
          "63323-563-01",
          "63323-563-10",
          "14789-500-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363323563011"
        ],
        "nui": [
          "N0000175634",
          "N0000175632"
        ],
        "pharm_class_epc": [
          "Antifibrinolytic Agent [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Fibrinolysis [PE]"
        ],
        "unii": [
          "6T84R30KC1"
        ]
      },
      "product_type": "Drugs",
      "event_id": "66678",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "3 Corporate Dr",
      "address_2": "",
      "postal_code": "60047-8930",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: Nationwide",
      "recall_number": "D-1034-2014",
      "product_description": "Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only.  Mfd by: Fresenius Kabi USA, LLC   Packaged under two labels: 1) Mfd for: APP Pharmaceuticals, LLC; Schaumburg, IL 60173, NDC 63323-563-10, and 2) Mfd in USA; for Nexus Pharmaceuticals Inc; Vernon Hills, IL 60061.  NDC 14789-500-10.",
      "product_quantity": "121,456 vials",
      "reason_for_recall": "Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial container.",
      "recall_initiation_date": "20131031",
      "center_classification_date": "20140123",
      "termination_date": "20160107",
      "report_date": "20140129",
      "code_info": "National Drug Code (NDC): 63323-563-10;    Lot Numbers and (Expiration Dates): 011713 (01/2015); 012213 (01/2015), 032913 (03/2015), 041613 (04/2015); 042513 (04/2015), 042613 (04/2015), 052213 (05/2015), 092612 (09/2014), 111512 (11/2014)    NDC: 14789-500-10;   122911 (12/2013), 123011 (12/2013)",
      "more_code_info": ""
    }
  ]
}