LOTRIMIN AF Jock Itch Powder 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%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whi…

Recall number

D-0237-2022

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%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8