{
  "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": "Ongoing",
      "city": "New York",
      "state": "NY",
      "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": "88077",
      "recalling_firm": "Pfizer Inc.",
      "address_1": "235 East 42nd Street",
      "address_2": "",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0700-2021",
      "product_description": "Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland,  NDC 0069-0471-03.",
      "product_quantity": "350,985 cartons",
      "reason_for_recall": "CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit",
      "recall_initiation_date": "20210609",
      "center_classification_date": "20210730",
      "report_date": "20210811",
      "code_info": "Lots 00020231, Exp 30 Sept 2021;  00020232, Exp 30 Nov 2021;  00020357, Exp 31 Dec 2021;  00020358, Exp 31, Jan 2022;  00020716, Exp 31, Jan 2022 ;  ET1600, Exp 31, Jan 2023;  ET1607, Exp 31, Jan 2023 &  ET1609, Exp 31, Jan 2023.",
      "more_code_info": ""
    }
  ]
}