FDA-Drug2021-11-24Class I

Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3.

Bayer Healthcare Pharmaceuticals Inc.
Hazard

Chemical Contamination: presence of benzene

Sold states
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Affected count
4,990,860 cans
Manufactured in
100 Bayer Blvd, N/A, Whippany, NJ, United States
Products
Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0251-2022

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