Drug recall D-0244-2022

Class II Terminated reported Nov 24, 2021

Product

Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland 86951967, UPC 3 11017 41007 3, NDC 11523-0072-5

Reason for recall

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

Lots and codes

Lot # TN00086, CV015YU, EXP 10/31/2022; TN00273, EXP 12/31/2022; TN005RW, Exp 5/31/2023;

Recall details

Recalling firm
Bayer Healthcare Pharmaceuticals Inc., Whippany, NJ
Quantity
592,416 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