{
  "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": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Shirley",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA071192"
        ],
        "brand_name": [
          "AMINOCAPROIC ACID"
        ],
        "generic_name": [
          "AMINOCAPROIC ACID"
        ],
        "manufacturer_name": [
          "American Regent, Inc."
        ],
        "product_ndc": [
          "0517-9120"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "AMINOCAPROIC ACID"
        ],
        "rxcui": [
          "238719"
        ],
        "spl_id": [
          "c62d23ae-6f20-4a53-94e4-4ba5d25b7231"
        ],
        "spl_set_id": [
          "f4f65667-c349-420b-b7b7-f20f3a4e4d4e"
        ],
        "package_ndc": [
          "0517-9120-25",
          "0517-9120-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0305179120253"
        ],
        "nui": [
          "N0000175634",
          "N0000175632"
        ],
        "pharm_class_epc": [
          "Antifibrinolytic Agent [EPC]"
        ],
        "pharm_class_pe": [
          "Decreased Fibrinolysis [PE]"
        ],
        "unii": [
          "U6F3787206"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99503",
      "recalling_firm": "American Regent, Inc.",
      "address_1": "5 Ramsay Rd",
      "address_2": "",
      "postal_code": "11967-4701",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide within the U.S",
      "recall_number": "D-0794-2026",
      "product_description": "AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01),  and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 0517-9120-25), Rx Only, American Regent, Inc., Shirley, NY 11967.",
      "product_quantity": "63,200 vials",
      "reason_for_recall": "Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde",
      "recall_initiation_date": "20260724",
      "center_classification_date": "20260826",
      "report_date": "20260826",
      "code_info": "Lot #: 24299, Exp. Date: 8/31/2026.",
      "more_code_info": ""
    }
  ]
}