Bayer Healthcare Pharmaceuticals Inc. recalls Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product
Recalled November 24, 2021 · FDA recall D-0245-2022 · Bayer Healthcare Pharmaceuticals
Hazard
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. · FDA Class II
Units
2,841,012 cans
Sold at
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Description
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Product
Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product of Finland 20006106, (c) Product of Ireland with Instant redeemable coupon ( IRC); Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.
Manufacturer(s)
Bayer Healthcare Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →