PlainRecalls
FDA Drug Moderate Class II Terminated

LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8

Reported: November 24, 2021 Initiated: October 1, 2021 #D-0237-2022

Product Description

LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8

Reason for Recall

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

Details

Units Affected
4,546,152 cans
Distribution
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Location
Whippany, NJ

Frequently Asked Questions

What product was recalled?
LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8. Recalled by Bayer Healthcare Pharmaceuticals Inc.. Units affected: 4,546,152 cans.
Why was this product recalled?
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 24, 2021. Severity: Moderate. Recall number: D-0237-2022.