D-0238-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 24, 2021
- Initiation Date
- October 1, 2021
- Termination Date
- June 26, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,816,468 cans
Product Description
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, ,
Reason for Recall
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Distribution Pattern
Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Code Information
Lot # (a) CV017D9, EXP 10/31/2021; CV01940, EXP 11/30/2021; CV01CD9, EXP 4/30/2022; CV01D9T, CV01DZ3, EXP 6/30/2022; CV01EPP, EXP 7/31/2022; TN000TT, EXP 10/31/2022; TN003CG, EXP 1/31/2023; TN003CH, TN00407, EXP 3/31/2023; TN0041V, EXP 6/30/2023; TN0056W, EXP 7/31/2022; TN005P4, EXP 8/31/2022; TN006MJ, EXP 9/30/2022; (b) CV01940, CV01940A, EXP 11/30/2021; CV01AP2, EXP 02/28/2022; CV01D9T, CV01D9TA, CV01DZ3, EXP 06/30/2022; CV01EPP, EXP 07/31/2022; TN005P4, EXP 08/31/2022; TN000TT, TN000TTA, EXP 10/31/2022; TN003CG, EXP 01/31/2023; TN003CH, TN003CHA, TN00407, TN006TD, TN006TDB, TN00407A, EXP 03/31/2023; TN0041V, EXP 06/30/2023