{
  "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": "Dublin",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA021928"
        ],
        "brand_name": [
          "CHANTIX"
        ],
        "generic_name": [
          "VARENICLINE TARTRATE"
        ],
        "manufacturer_name": [
          "Pfizer Laboratories Div Pfizer Inc"
        ],
        "product_ndc": [
          "0069-0468",
          "0069-0469",
          "0069-0471"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VARENICLINE TARTRATE"
        ],
        "rxcui": [
          "636671",
          "636676",
          "637188",
          "637190",
          "749289",
          "749788",
          "795735",
          "795737"
        ],
        "spl_id": [
          "09cce88b-e4f0-48b7-ac05-54d97976b4c5"
        ],
        "spl_set_id": [
          "f0ff4f27-5185-4881-a749-c6b7a0ca5696"
        ],
        "package_ndc": [
          "0069-0468-56",
          "0069-0469-56",
          "0069-0469-28",
          "0069-0471-03",
          "0069-0471-28"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300690469560",
          "0300690468563",
          "0300690471280"
        ],
        "unii": [
          "82269ASB48"
        ]
      },
      "product_type": "Drugs",
      "event_id": "87512",
      "recalling_firm": "Cardinal Health Inc.",
      "address_1": "7000 Cardinal Pl",
      "address_2": "N/A",
      "postal_code": "43017-1091",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "FL, GA, SC",
      "recall_number": "D-0555-2021",
      "product_description": "Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only ; Rx only  Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY ,10017NDC 0069-0469-56",
      "product_quantity": "848 bottles",
      "reason_for_recall": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
      "recall_initiation_date": "20210315",
      "center_classification_date": "20210524",
      "termination_date": "20240617",
      "report_date": "20210602",
      "code_info": "EM1069"
    }
  ]
}