{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Ridgefield",
      "state": "CT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA206111"
        ],
        "brand_name": [
          "SYNJARDY"
        ],
        "generic_name": [
          "EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Boehringer Ingelheim Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "0597-0159",
          "0597-0175",
          "0597-0180",
          "0597-0168"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "EMPAGLIFLOZIN",
          "METFORMIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "1664315",
          "1664321",
          "1664323",
          "1664325",
          "1664326",
          "1664328",
          "1665367",
          "1665369"
        ],
        "spl_id": [
          "06cb5e7a-ca7a-474a-a968-b3ddc7af1c43"
        ],
        "spl_set_id": [
          "0fdd0255-0055-65f3-b2c0-db8fbb87beae"
        ],
        "package_ndc": [
          "0597-0159-60",
          "0597-0159-18",
          "0597-0159-66",
          "0597-0175-60",
          "0597-0175-18",
          "0597-0175-66",
          "0597-0180-60",
          "0597-0180-18",
          "0597-0180-66",
          "0597-0168-60",
          "0597-0168-18",
          "0597-0168-66"
        ],
        "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",
          "786Z46389E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80961",
      "recalling_firm": "Boehringer Ingelheim Pharmaceuticals, Inc.",
      "address_1": "900 Ridgebury Rd",
      "address_2": "",
      "postal_code": "06877-1058",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1217-2018",
      "product_description": "Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottle. Distributed by: Boehinger Ingelheim  (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877. Made in Germany. Marketed by: BI Pharmaceuticals, Inc. Ridgefield, CT 06877 and Eli Lilly and Company Indianapolis IN 46285 NDC 0597-0175-18",
      "product_quantity": "998 180-count bottles",
      "reason_for_recall": "Cross Contamination With Other Products:",
      "recall_initiation_date": "20180904",
      "center_classification_date": "20180927",
      "termination_date": "20190819",
      "report_date": "20181003",
      "code_info": "Lot # 603968 EXP 4/2019",
      "more_code_info": ""
    }
  ]
}