Bayer Healthcare Pharmaceuticals Inc. recalls LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-
Recalled November 24, 2021 · FDA recall D-0238-2022 · Bayer Healthcare Pharmaceuticals
Hazard
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. · FDA Class II
Units
3,816,468 cans
Sold at
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Description
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Product
LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-2 UPC 3 11017 41025 7; (b) 3 pack, NDC 11523-0544-2, UPC 0 41100 58594 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, ,
Manufacturer(s)
Bayer Healthcare Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →