FDA recall D-0251-2022

Bayer Healthcare Pharmaceuticals Inc. · Class I · 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, 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

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-0251-2022