Bayer Healthcare Pharmaceuticals Inc. — Class II Recall

Product

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

Reason

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

Classification

Class II

Status

Terminated

Lot

Lot #: CV01BEP, 3/31/2022; CV01D6W, 5/31/2022; CV01EV0, 7/31/2022; TN0004J, 9/30/2022; TN001AE, 11/30/2022; TN003C3, 1/31/2023; TN003C4, 2/28/2023; TN003HT, 3/31/2023; TN003CW, 4/30/2023; TN0045J, 6/30/2023; TN0040C, 7/31/2023; TN004BU, 8/31/2023; TN006MB, 9/30/2022;

Date

2021-11-24

Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.