{
  "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": [
          "ANDA208891"
        ],
        "brand_name": [
          "WIXELA INHUB"
        ],
        "generic_name": [
          "FLUTICASONE PROPIONATE AND SALMETEROL"
        ],
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "0378-9320",
          "0378-9321",
          "0378-9322"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "FLUTICASONE PROPIONATE",
          "SALMETEROL XINAFOATE"
        ],
        "rxcui": [
          "896184",
          "896209",
          "896228",
          "2110510",
          "2110513",
          "2110516"
        ],
        "spl_id": [
          "03d33612-03b4-4a2c-ba86-47816db363ce"
        ],
        "spl_set_id": [
          "3beef422-8a07-4a45-9ba6-414511e4b7e2"
        ],
        "package_ndc": [
          "0378-9320-32",
          "0378-9321-32",
          "0378-9322-32"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "O2GMZ0LF5W",
          "6EW8Q962A5"
        ]
      },
      "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-0202-2024",
      "product_description": "Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG,  60 Doses of Inhalation Powder, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505.  NDC: 0378-9320-32",
      "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 62002532",
      "more_code_info": ""
    }
  ]
}