FDA recall D-0243-2022

Bayer Healthcare Pharmaceuticals Inc. · Class II · drug

Product

Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, (c) Product of Ireland 87022897, with an instant redeemable coupon (IRC) tag attached to the can; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3 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

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-0243-2022