D-0245-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 24, 2021
- Initiation Date
- October 1, 2021
- Termination Date
- June 26, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,841,012 cans
Product Description
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 for Recall
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Distribution Pattern
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Code Information
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