Tinactin LIQUID SPRAY NET WT150g can recalled over manufacturing violations

Recall date

October 1, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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…

Recall number

D-0243-2022

FDA classification

Class II

Brand / firm

Bayer Healthcare Pharmaceuticals Inc.

Sold / distributed

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.