FDA-Drug2021-11-24Class II
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, ,
Bayer Healthcare Pharmaceuticals Inc.
Hazard
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Sold states
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Affected count
3,816,468 cans
Manufactured in
100 Bayer Blvd, N/A, Whippany, NJ, United States
Products
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, ,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0238-2022Don't want to check this manually?
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