PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: November 24, 2021 Initiated: October 1, 2021 #D-0248-2022

Product Description

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

Details

Units Affected
3,816,468 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%), 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. Recalled by Bayer Healthcare Pharmaceuticals Inc.. Units affected: 3,816,468 cans.
Why was this product recalled?
Chemical Contamination: presence of benzene
Which agency issued this recall?
This recall was issued by the FDA Drug on November 24, 2021. Severity: Critical. Recall number: D-0248-2022.