{
  "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": "2026-07-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA020931"
        ],
        "brand_name": [
          "TIKOSYN"
        ],
        "generic_name": [
          "DOFETILIDE"
        ],
        "manufacturer_name": [
          "Pfizer Laboratories Div Pfizer Inc"
        ],
        "product_ndc": [
          "0069-5800",
          "0069-5810",
          "0069-5820"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DOFETILIDE"
        ],
        "rxcui": [
          "284404",
          "284405",
          "285016",
          "310003",
          "310004",
          "310005"
        ],
        "spl_id": [
          "0109bfef-980f-4bc8-a802-3d3c45587456"
        ],
        "spl_set_id": [
          "02438044-d6a3-49e9-a1ac-3aad21ef2c8c"
        ],
        "package_ndc": [
          "0069-5800-61",
          "0069-5800-60",
          "0069-5800-43",
          "0069-5810-61",
          "0069-5810-60",
          "0069-5810-43",
          "0069-5820-61",
          "0069-5820-60",
          "0069-5820-43"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300695810602",
          "0300695800603",
          "0300695820601"
        ],
        "nui": [
          "N0000175426"
        ],
        "pharm_class_epc": [
          "Antiarrhythmic [EPC]"
        ],
        "unii": [
          "R4Z9X1N2ND"
        ]
      },
      "product_type": "Drugs",
      "event_id": "69724",
      "recalling_firm": "Pfizer Inc.",
      "address_1": "235 East 42nd Street",
      "address_2": "N/A",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Pfizer shipped the affected product to 4,447 direct accounts.     No federal government accounts received the affected product directly from Pfizer Inc.",
      "recall_number": "D-0292-2015",
      "product_description": "Tikosyn (dofetilide) 125 mcg (0.125 mg), a) 14-count bottle (NDC 0069-5800-61), b) 60-count bottle (NDC 0069-5800-60), Rx Only, Manufactured by Pfizer Labs, Division of Pfizer, Inc., NY, NY 10017.",
      "product_quantity": "31,569 HDPE Bottles",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.",
      "recall_initiation_date": "20141203",
      "center_classification_date": "20141209",
      "termination_date": "20160927",
      "report_date": "20141217",
      "code_info": "Lot # a) H79652, Exp. 10/15; b) H79653, Exp. 10/15"
    }
  ]
}