Recalls / Class II
Class IID-0241-2022
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
- Affected lot / code info
- 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;
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
- 1,801,332 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-0241-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.