LOTRIMIN AF 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%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544…

Recall number

D-0238-2022

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%) 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, ,