FDA-Drug2021-11-24Class II
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
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
738,432 cans
Manufactured in
100 Bayer Blvd, N/A, Whippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0242-2022Don't want to check this manually?
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