{
  "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": "Whippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M005"
        ],
        "brand_name": [
          "TINACTIN"
        ],
        "generic_name": [
          "TOLNAFTATE"
        ],
        "manufacturer_name": [
          "Bayer HealthCare LLC."
        ],
        "product_ndc": [
          "11523-4162"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TOLNAFTATE"
        ],
        "rxcui": [
          "705934",
          "705936"
        ],
        "spl_id": [
          "4536ec39-08e4-6eed-e063-6294a90a24c4"
        ],
        "spl_set_id": [
          "5f95be36-6efa-4dfb-9a40-88f4ce1de2b3"
        ],
        "package_ndc": [
          "11523-4162-1",
          "11017-410-00"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0311017410004",
          "311017410004"
        ],
        "unii": [
          "06KB629TKV"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88677",
      "recalling_firm": "Bayer Healthcare Pharmaceuticals Inc.",
      "address_1": "100 Bayer Blvd",
      "address_2": "N/A",
      "postal_code": "07981-1544",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.",
      "recall_number": "D-0242-2022",
      "product_description": "Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of Finland 86568411; (b) UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981",
      "product_quantity": "738,432 cans",
      "reason_for_recall": "cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.",
      "recall_initiation_date": "20211001",
      "center_classification_date": "20211118",
      "termination_date": "20230626",
      "report_date": "20211124",
      "code_info": "Lot # (a) TN004BW, EXP 7/31/2022,   (b) TN00678, EXP 8/31/2022; TN00679, EXP 9/30/2022;",
      "more_code_info": ""
    }
  ]
}