Drug recall D-0239-2022

Class II Terminated reported Nov 24, 2021

Product

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 59036 7, NDC 11523-0010-1.

Reason for recall

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

Lots and codes

Lot # TN005K4, EXP 4/30/2022; TN005K8, EXP 6/30/2022

Recall details

Recalling firm
Bayer Healthcare Pharmaceuticals Inc., Whippany, NJ
Quantity
77,076 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

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