FDA-Drug2021-11-24Class II

LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a) single pack, UPC 0 41100 58720 6, NDC 11523-0010-2; (b) 3-pack, UPC 0 41100 58961 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland,

Bayer Healthcare Pharmaceuticals Inc.
Hazard

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

Sold states
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Affected count
579,456 cans
Manufactured in
100 Bayer Blvd, N/A, Whippany, NJ, United States
Products
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a) single pack, UPC 0 41100 58720 6, NDC 11523-0010-2; (b) 3-pack, UPC 0 41100 58961 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland,

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0240-2022

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