Recalls / Class II
Class IID-0238-2022
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, ,
- Affected lot / code info
- 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
Why it was recalled
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Recalling firm
- Firm
- Bayer Healthcare Pharmaceuticals Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 100 Bayer Blvd, N/A, Whippany, New Jersey 07981-1544
Distribution
- Quantity
- 3,816,468 cans
- Distribution pattern
- Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Timeline
- Recall initiated
- 2021-10-01
- FDA classified
- 2021-11-18
- Posted by FDA
- 2021-11-24
- Terminated
- 2023-06-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0238-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.