{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA205035"
        ],
        "brand_name": [
          "TRANEXAMIC ACID"
        ],
        "generic_name": [
          "TRANEXAMIC ACID"
        ],
        "manufacturer_name": [
          "Eugia US LLC"
        ],
        "product_ndc": [
          "55150-188"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "TRANEXAMIC ACID"
        ],
        "rxcui": [
          "238720"
        ],
        "spl_id": [
          "694c8b46-6656-45bb-bd9d-9cd34eab9755"
        ],
        "spl_set_id": [
          "246a3c6c-a7fb-45c7-9509-49a48a5bdcc6"
        ],
        "package_ndc": [
          "55150-188-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355150188109"
        ],
        "nui": [
          "N0000175634",
          "N0000175632"
        ],
        "pharm_class_epc": [
          "Antifibrinolytic Agent [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Fibrinolysis [PE]"
        ],
        "unii": [
          "6T84R30KC1"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90897",
      "recalling_firm": "AuroMedics Pharma LLC",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "N/A",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Nationwide in the USA",
      "recall_number": "D-1551-2022",
      "product_description": "Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10",
      "product_quantity": "88080 vials",
      "reason_for_recall": "Presence of Particulate Matter: Piece of metal found in a vial",
      "recall_initiation_date": "20220926",
      "center_classification_date": "20220930",
      "report_date": "20221012",
      "code_info": "Lot: CTA210006, Exp. 02/2024"
    }
  ]
}