PlainRecalls
FDA Drug Critical Class I Terminated

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.

Reported: November 24, 2021 Initiated: October 1, 2021 #D-0251-2022

Product Description

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.

Reason for Recall

Chemical Contamination: presence of benzene

Details

Units Affected
4,990,860 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%) 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.. Recalled by Bayer Healthcare Pharmaceuticals Inc.. Units affected: 4,990,860 cans.
Why was this product recalled?
Chemical Contamination: presence of benzene
Which agency issued this recall?
This recall was issued by the FDA Drug on November 24, 2021. Severity: Critical. Recall number: D-0251-2022.