{
  "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": "2026-06-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Lake Zurich",
      "state": "IL",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA213708"
        ],
        "brand_name": [
          "EPINEPHRINE"
        ],
        "generic_name": [
          "EPINEPHRINE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-696"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAOCULAR",
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "EPINEPHRINE"
        ],
        "rxcui": [
          "1660014"
        ],
        "spl_id": [
          "e61f344b-7215-425c-9767-fd4210748221"
        ],
        "spl_set_id": [
          "a6afb9e8-1db9-480c-8d31-58c5c870ca49"
        ],
        "package_ndc": [
          "63323-696-02",
          "63323-696-25"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363323696023"
        ],
        "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": "98997",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "3 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "60047-8930",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0581-2026",
      "product_description": "Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)",
      "product_quantity": "898,050 vials",
      "reason_for_recall": "Failed Impurities/Degradations Specifications",
      "recall_initiation_date": "20260514",
      "center_classification_date": "20260605",
      "report_date": "20260617",
      "code_info": "Batch # 6133313, 6133314, Exp Date: 06/2026; Batch # 6133315, Exp Date: 07/2026; Batch # 6133682, Exp Date: 09/2026; Batch # 6134812, 6134813, Exp Date: 04/2027."
    }
  ]
}