{
  "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": "Morgantown",
      "state": "WV",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA078702"
        ],
        "brand_name": [
          "CANDESARTAN CILEXETIL"
        ],
        "generic_name": [
          "CANDESARTAN CILEXETIL"
        ],
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "0378-3224",
          "0378-3225",
          "0378-3231",
          "0378-3232"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CANDESARTAN CILEXETIL"
        ],
        "rxcui": [
          "153822",
          "153823",
          "577776",
          "639537"
        ],
        "spl_id": [
          "62815e9d-598e-4b5f-b33b-3a9659eec024"
        ],
        "spl_set_id": [
          "904b357e-97bf-475e-90a5-f0449f2a428e"
        ],
        "package_ndc": [
          "0378-3224-93",
          "0378-3224-77",
          "0378-3225-93",
          "0378-3225-77",
          "0378-3231-93",
          "0378-3231-77",
          "0378-3232-93",
          "0378-3232-77"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0303783232935",
          "0303783225937",
          "0303783224930"
        ],
        "unii": [
          "R85M2X0D68"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88609",
      "recalling_firm": "Viatris",
      "address_1": "781 Chestnut Ridge Rd",
      "address_2": "N/A",
      "postal_code": "26505-2730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed nationwide.",
      "recall_number": "D-0798-2021",
      "product_description": "Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93",
      "product_quantity": "21,094",
      "reason_for_recall": "Failed Impurities/Degradation Specifications; out of specification for Related Compound",
      "recall_initiation_date": "20210913",
      "center_classification_date": "20210914",
      "termination_date": "20220428",
      "report_date": "20210922",
      "code_info": "Lot # 3107334, exp. date October 2021",
      "more_code_info": ""
    }
  ]
}