FDA-Drug2021-11-24Class II
Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4327-1; (b) 3-pack UPC 0 41100 58593 6; 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
1,801,332 cans
Manufactured in
100 Bayer Blvd, N/A, Whippany, NJ, United States
Products
Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4327-1; (b) 3-pack UPC 0 41100 58593 6; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0241-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief