MedicineWatch US
Class II Recall

Bayer Healthcare Pharmaceuticals Inc.

Product
Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product of Finland 20006106, (c) Product of Ireland with Instant redeemable coupon ( IRC); Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.
Reason
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Classification
Class II
Status
Terminated
Lot
Lot # (a) CV015YT, EXP 10/31/2021; CV01AE7, EXP 2/28/2022; CV01CY2, EXP 4/30/2022'; CV01E6P, EXP 8/31/2022; TN00085, TN001EK, EXP 10/31/2022; TN001ZV, TN00274, EXP 12/31/2022; TN003CU, EXP 1/31/2023; TN003CV, EXP 3/31/2023; TN0047H, EXP 4/30/2023; TN0047R, EXP 5/31/2023; (b)TN0067B, EXP 9/30/2022; TN006AT, EXP 12/31/2022; TN006TA, EXP 2/28/2023; (c) CV01E6PV, CV01E6PD, CV01E6PC, CV01E6PBV, CV01E6PAV, EXP 8/31/2022
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.