Drug recall D-0241-2022

Class II Terminated reported Nov 24, 2021

Product

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

Reason for recall

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

Lots and codes

Lot # (a) TN000TR, EXP 10/31/2021; TN0011B, EXP 11/30/2021; TN003CC, TN003CD, EXP 02/28/2022; TN0040B, EXP 05/31/2022; TN0041U, EXP 06/30/2022; TN004BK, EXP 08/31/2022; TN005P3, EXP 10/31/2022; TN006AP, TN006MC, EXP 01/31/2023; TN006TB, EXP 04/30/2023; (b) TN000TR, EXP 10/31/2021; TN0011B, TN0011BA, EXP 11/30/2021; TN003CD, TN003CDA, TN003CDB,EXP 02/28/2022; TN0040BA, TN0040BV, EXP 05/31/2022; TN0041U,EXP 06/30/2022; TN004BK, EXP 08/31/2022; TN006MC, EXP 01/31/2023;

Recall details

Recalling firm
Bayer Healthcare Pharmaceuticals Inc., Whippany, NJ
Quantity
1,801,332 cans
Distribution
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Type
Voluntary: Firm initiated
Recall initiated
October 1, 2021
Terminated
June 26, 2023