{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Dublin",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA204629"
        ],
        "brand_name": [
          "JARDIANCE"
        ],
        "generic_name": [
          "EMPAGLIFLOZIN"
        ],
        "manufacturer_name": [
          "Boehringer Ingelheim Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "0597-0152",
          "0597-0153"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "EMPAGLIFLOZIN"
        ],
        "rxcui": [
          "1545658",
          "1545664",
          "1545666",
          "1545668"
        ],
        "spl_id": [
          "09daa78d-f417-436c-a29e-029c015ca6d6"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "0597-0152-90",
          "0597-0152-07",
          "0597-0152-70",
          "0597-0152-37",
          "0597-0152-30",
          "0597-0153-37",
          "0597-0153-30",
          "0597-0153-90",
          "0597-0153-07",
          "0597-0153-70"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000187059",
          "N0000187058"
        ],
        "pharm_class_epc": [
          "Sodium-Glucose Cotransporter 2 Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Sodium-Glucose Transporter 2 Inhibitors [MoA]"
        ],
        "unii": [
          "HDC1R2M35U"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89450",
      "recalling_firm": "CARDINAL HEALTHCARE",
      "address_1": "7200 Cardinal Pl W",
      "address_2": "",
      "postal_code": "43017-1094",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide USA",
      "recall_number": "D-0185-2024",
      "product_description": "Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877.  NDC: 0597-0153-37",
      "product_quantity": "1 unit",
      "reason_for_recall": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.",
      "recall_initiation_date": "20220126",
      "center_classification_date": "20231226",
      "termination_date": "20240929",
      "report_date": "20240103",
      "code_info": "Batch D41919",
      "more_code_info": ""
    }
  ]
}