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…

Recall date

October 1, 2021

Source

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

Recall number

D-0253-2022

FDA classification

Class I

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

Chemical Contamination: presence of benzene

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of Finland 20006106; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.