Recalls / Class II
Class IID-0236-2022
Product
LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3
- Affected lot / code info
- Lot # TN00082, Exp 9/30/2021;TN000TU, TN000TV, Exp. 10/31/2021; TN00236, Exp. 1/31/2022; TN003C8, Exp 2/28/2022; TN003C9, Exp 3/31/2022; TN003GS, Exp 4/30/2022; TN0041W, Exp 6/30/2022; TN006W8, Exp 8/31/2022; TN005P5, Exp 9/30/2022; TN006MZ, Exp 2/28/2023;
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
- 2,817,468 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-0236-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.