Drug recall D-0242-2022

Class II Terminated reported Nov 24, 2021

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

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