PlainRecalls
FDA Drug Moderate Class II Terminated

Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland 86951967, UPC 3 11017 41007 3, NDC 11523-0072-5

Reported: November 24, 2021 Initiated: October 1, 2021 #D-0244-2022

Product Description

Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland 86951967, UPC 3 11017 41007 3, NDC 11523-0072-5

Reason for Recall

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

Details

Units Affected
592,416 cans
Distribution
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Location
Whippany, NJ

Frequently Asked Questions

What product was recalled?
Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland 86951967, UPC 3 11017 41007 3, NDC 11523-0072-5. Recalled by Bayer Healthcare Pharmaceuticals Inc.. Units affected: 592,416 cans.
Why was this product recalled?
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 24, 2021. Severity: Moderate. Recall number: D-0244-2022.