Drug recall D-0242-2022
Product
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
Reason for recall
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Lots and codes
Lot # (a) TN004BW, EXP 7/31/2022, (b) TN00678, EXP 8/31/2022; TN00679, EXP 9/30/2022;
Recall details
- Recalling firm
- Bayer Healthcare Pharmaceuticals Inc., Whippany, NJ
- Quantity
- 738,432 cans
- Distribution
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 1, 2021
- Terminated
- June 26, 2023
Related products
- Tinactin – drug information
- NDC 11523-4162 Tinactin Antifungal · Tolnaftate 10 mg/g · Bayer HealthCare LLC.