{
  "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": [
          "11523-0165"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TOLNAFTATE"
        ],
        "rxcui": [
          "209674",
          "313421"
        ],
        "spl_id": [
          "4526e2eb-ee8c-3ac4-e063-6394a90a133f"
        ],
        "spl_set_id": [
          "bb878f31-2189-4427-aacf-5bce96d75978"
        ],
        "package_ndc": [
          "11523-0165-3"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0311017410059",
          "311017410059"
        ],
        "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-0243-2022",
      "product_description": "Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product of  Ireland 87022897,  (c)  Product of  Ireland 87022897, with an instant redeemable coupon (IRC) tag attached to the can; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3     Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can,  Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981,  UPC 3 11017 41005 9, NDC 11523-0165-3.",
      "product_quantity": "4,990,860 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)TN0060U,  TN0060V, TN0060W, EXP 7/31/2022; TN0060X, TN0060Y, TN0060Z, TN006CJ, TN006CK, TN006CM, TN00610, EXP 9/30/2022; TN006YW, EXP 10/31/2022; TN006MY, TN006YX, TN006YY, EXP 12/31/2022; TN007EN, TN007EP, TN007ER, EXP 2/28/2023;    (b)CV016TH, CV016TJ, CV017D8, CV017D7, EXP 10/31/2021; CV017XS, EXP 11/30/2021;  CV01980, CV019DS, EXP 12/31/2021;  CV01A72, CV01A73, CV01AE6, EXP 1/31/2022; CV01AUA, CV01B1E, EXP 2/28/2022; CV01BNE, EXP 3/31/2022; CV01BVU, EXP 3/31/2022; CV01CT6, CV01CY1, EXP 4/30/2022; CV01D2G, EXP 5/31/2022; CV01DRX, CV01DRY, CV01E2T, EXP 6/30/2022; CV01E2W, CV01E2X, EXP 7/31/2022; CV01E2U, EXP 7/31/2022; CV01E2V, EXP 8/31/2022; TN001V6, EXP 11/30/2022; TN00243, EXP 12/31/2022;  TN0024B, TN0024C,  TN0024D, TN0024E, TN003C6, EXP 1/31/2023; TN00408, TN00409, TN0047J, TN0047K, TN0040A, EXP 4/30/2022,   (c) CV01DRX, CV01DRY, CV01E2T, EXP 6/30/2022",
      "more_code_info": ""
    }
  ]
}