{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Durham",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA213338"
        ],
        "brand_name": [
          "DOFETILIDE"
        ],
        "generic_name": [
          "DOFETILIDE"
        ],
        "manufacturer_name": [
          "Accord Healthcare, Inc."
        ],
        "product_ndc": [
          "16729-490",
          "16729-491",
          "16729-492"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DOFETILIDE"
        ],
        "rxcui": [
          "310003",
          "310004",
          "310005"
        ],
        "spl_id": [
          "40bca241-47f2-b7f0-e063-6294a90a1680"
        ],
        "spl_set_id": [
          "4c1a5a6d-bd69-473c-8caa-d0d242b7708d"
        ],
        "package_ndc": [
          "16729-490-12",
          "16729-490-59",
          "16729-491-12",
          "16729-491-59",
          "16729-492-12",
          "16729-492-59"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175426"
        ],
        "pharm_class_epc": [
          "Antiarrhythmic [EPC]"
        ],
        "unii": [
          "R4Z9X1N2ND"
        ],
        "upc": [
          "316729492126"
        ]
      },
      "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-0385-2023",
      "product_description": "Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703.  Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA  NDC 16729-492-12 UPC 3 16729 49212 6",
      "product_quantity": "113,003 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:  P2101582, P2101661, P2101482, P2101686, Exp. Date 2/28/2023; P2102581, P2102598, Exp. Date 4/30/2023; P2103623, P2103653, P2103670, Exp. Date 5/31/2023; P2104463, P2104385, P2104386, P2104472, P2104709, P2104714, Exp. Date 6/30/2023; P2200797, P2200773, P2200831, Exp. Date 12/31/2023; P2201017, P2201081, P2201056, Exp. Date 1/31/2024; P2200819, Exp. Date 12/31/2024; P2202611, P2202616, Exp. Date 4/30/2025, P2203467, Exp. Date 5/31/2025",
      "more_code_info": ""
    }
  ]
}