FDA recall D-0248-2022

Bayer Healthcare Pharmaceuticals Inc. · Class I · drug

Product

LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7

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-0248-2022