Drug recall D-0253-2022

Class I Terminated reported Nov 24, 2021

Product

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.

Reason for recall

Chemical Contamination: presence of benzene

Lots and codes

Lot # (a)CV015YS, EXP 9/30/2021 (b) TN008CT, TN007TJ, EXP 3/31/2023

Recall details

Recalling firm
Bayer Healthcare Pharmaceuticals Inc., Whippany, NJ
Quantity
2,841,012 cans
Distribution
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Type
Voluntary: Firm initiated
Recall initiated
October 1, 2021
Terminated
June 26, 2023