Lotrimin AF Liquid Spray can recalled over manufacturing violations

Recall date

October 1, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Bayer Healthcare Pharmaceuticals Inc. recalls Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 407…

Recall number

D-0241-2022

FDA classification

Class II

Brand / firm

Bayer Healthcare Pharmaceuticals Inc.

Sold / distributed

Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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