{
  "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": "2026-09-23",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Shirley",
      "state": "NY",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA217192"
        ],
        "brand_name": [
          "EPINEPHRINE"
        ],
        "generic_name": [
          "EPINEPHRINE"
        ],
        "manufacturer_name": [
          "American Regent, Inc."
        ],
        "product_ndc": [
          "0517-3030"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "EPINEPHRINE"
        ],
        "rxcui": [
          "310132"
        ],
        "spl_id": [
          "495f1aad-cf64-41ab-9f9e-59f6ebeb44aa"
        ],
        "spl_set_id": [
          "61cacda5-64ee-45ca-b94c-e8640c43e581"
        ],
        "package_ndc": [
          "0517-3030-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000209",
          "N0000000245",
          "N0000175552",
          "N0000175555",
          "N0000175570",
          "M0003647"
        ],
        "pharm_class_moa": [
          "Adrenergic alpha-Agonists [MoA]",
          "Adrenergic beta-Agonists [MoA]"
        ],
        "pharm_class_epc": [
          "alpha-Adrenergic Agonist [EPC]",
          "beta-Adrenergic Agonist [EPC]",
          "Catecholamine [EPC]"
        ],
        "pharm_class_cs": [
          "Catecholamines [CS]"
        ],
        "unii": [
          "YKH834O4BH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99670",
      "recalling_firm": "American Regent, Inc.",
      "address_1": "5 Ramsay Rd",
      "address_2": "",
      "postal_code": "11967-4701",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the U.S.A",
      "recall_number": "D-0865-2026",
      "product_description": "Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-3030-01",
      "product_quantity": "31,935 30mL-vials",
      "reason_for_recall": "Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.",
      "recall_initiation_date": "20260811",
      "center_classification_date": "20260922",
      "report_date": "20260916",
      "code_info": "Lots: 25128L1C0, Exp. August 31, 2026; 25280L1C0, Exp. October 31, 2026; 26108L1C0, Exp. July 31, 2027",
      "more_code_info": ""
    }
  ]
}