{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA210466"
        ],
        "brand_name": [
          "DOFETILIDE"
        ],
        "generic_name": [
          "DOFETILIDE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "47335-061",
          "47335-062",
          "47335-063"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DOFETILIDE"
        ],
        "rxcui": [
          "310003",
          "310004",
          "310005"
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        "spl_id": [
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        "spl_set_id": [
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        "package_ndc": [
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          "47335-061-66",
          "47335-061-79",
          "47335-062-86",
          "47335-062-66",
          "47335-062-79",
          "47335-063-86",
          "47335-063-66",
          "47335-063-79"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0347335062861",
          "0347335061864"
        ],
        "nui": [
          "N0000175426"
        ],
        "pharm_class_epc": [
          "Antiarrhythmic [EPC]"
        ],
        "unii": [
          "R4Z9X1N2ND"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92725",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-1082-2023",
      "product_description": "Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India,  Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86",
      "product_quantity": "360 60-count bottles",
      "reason_for_recall": "Out of Specification result observed in content uniformity testing",
      "recall_initiation_date": "20230718",
      "center_classification_date": "20230807",
      "termination_date": "20240226",
      "report_date": "20230816",
      "code_info": "Lot: DNE0217A, Exp 01/2025"
    }
  ]
}