{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Canonsburg",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA021269"
        ],
        "brand_name": [
          "CARDURA"
        ],
        "generic_name": [
          "DOXAZOSIN MESYLATE"
        ],
        "manufacturer_name": [
          "Viatris Specialty LLC"
        ],
        "product_ndc": [
          "58151-078",
          "58151-079"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DOXAZOSIN MESYLATE"
        ],
        "rxcui": [
          "636360",
          "636361",
          "1242404",
          "1242408"
        ],
        "spl_id": [
          "7fe31b0a-4fb2-427f-83e2-d5b957d6738b"
        ],
        "spl_set_id": [
          "355bcdce-0481-48ba-8ebd-2009106aaf77"
        ],
        "package_ndc": [
          "58151-078-93",
          "58151-079-93"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0358151078936"
        ],
        "unii": [
          "86P6PQK0MU"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96036",
      "recalling_firm": "Viatris Inc",
      "address_1": "1000 Mylan Blvd",
      "address_2": "",
      "postal_code": "15317-5853",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA nationwide.",
      "recall_number": "D-0204-2025",
      "product_description": "Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93",
      "product_quantity": "6,605/30 count bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.",
      "recall_initiation_date": "20241223",
      "center_classification_date": "20250116",
      "termination_date": "20251112",
      "report_date": "20250122",
      "code_info": "Lot# 8182298, Exp 10/31/2025",
      "more_code_info": ""
    }
  ]
}