Lotrimin AF recall: CGMP Deviations
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, ,
Why was Lotrimin AF recalled?
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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, ,
- Recalling firm
- Bayer Healthcare Pharmaceuticals Inc.
- Quantity
- 3,816,468 cans
- Distribution
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
- Recall date
- November 24, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)