FDA recall D-0245-2022

Bayer Healthcare Pharmaceuticals Inc. · Class II · drug

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, (c) Product of Ireland with Instant redeemable coupon ( IRC); Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2021-10-01
Report date
2021-11-24
Termination date
2023-06-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Whippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0245-2022