Bayer Healthcare Pharmaceuticals Inc. recalls Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product o
Recalled November 24, 2021 · FDA recall D-0243-2022 · 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
4,990,860 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%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, (c) Product of Ireland 87022897, with an instant redeemable coupon (IRC) tag attached to the can; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3 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.
Manufacturer(s)
Bayer Healthcare Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →