FDA recall D-0242-2022

Product

Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of Finland 86568411; (b) UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981

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-0242-2022