{
  "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": "Durham",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA202824"
        ],
        "brand_name": [
          "DOXAZOSIN"
        ],
        "generic_name": [
          "DOXAZOSIN"
        ],
        "manufacturer_name": [
          "Accord Healthcare Inc."
        ],
        "product_ndc": [
          "16729-211",
          "16729-414",
          "16729-213",
          "16729-415"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DOXAZOSIN MESYLATE"
        ],
        "rxcui": [
          "197625",
          "197626",
          "197627",
          "197628"
        ],
        "spl_id": [
          "1fbdaa94-b68a-b934-e063-6294a90a8b77"
        ],
        "spl_set_id": [
          "2830533c-ccdf-4401-b19c-763eeb1bc0a7"
        ],
        "package_ndc": [
          "16729-414-01",
          "16729-414-17",
          "16729-211-01",
          "16729-211-17",
          "16729-213-01",
          "16729-213-17",
          "16729-415-01",
          "16729-415-17"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "86P6PQK0MU"
        ],
        "upc": [
          "316729415019",
          "316729415170"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91657",
      "recalling_firm": "Accord Healthcare, Inc.",
      "address_1": "1009 Slater Rd Ste 210B",
      "address_2": "N/A",
      "postal_code": "27703-8446",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "United States including Puerto Rico and Canada",
      "recall_number": "D-0389-2023",
      "product_description": "Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3 16729 41501 9; b) 1,000 Tablets NDC 16729-415-17 UPC 3 16729 41517 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703.  Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA",
      "product_quantity": "31,116 bottles",
      "reason_for_recall": "CGMP Deviations: recalling drug products following an FDA inspection.",
      "recall_initiation_date": "20230207",
      "center_classification_date": "20230302",
      "termination_date": "20240422",
      "report_date": "20230308",
      "code_info": "Batches: a) R2200672, Exp. Date 5/31/2024; R2200673,  Exp. Date 9/30/2024; R2201097, Exp. Date 7/31/2025;  b) R2200678, Exp. Date 10/31/2024;",
      "more_code_info": ""
    }
  ]
}