Recalls / Class II
Class IID-0254-2022
Product
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC 11523-0010-2; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, Packaged with LOTRIMIN ULTRA (butenafine hydrochloride 1%) cream, UPC 0 11017 40823 9, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Japan, ECOM PK UPC 00041100590756 NDC 11523-0010-2
- Brand name
- Lotrimin Daily Prevention Deo
- Generic name
- Tolnaftate
- Active ingredient
- Tolnaftate
- Route
- Topical
- NDC
- 11523-0010
- FDA application
- M005
- Affected lot / code info
- Lot # NAA8997, EXP 01/31/2022; NAA8EK8, EXP 02/28/2022; NAA9E18, NAA9LFP, NAA9T53, NAA5RW, EXP 08/31/2022;
Why it was recalled
cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.
Recalling firm
- Firm
- Bayer Healthcare Pharmaceuticals Inc.
- Manufacturer
- Bayer HealthCare LLC.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 100 Bayer Blvd, N/A, Whippany, New Jersey 07981-1544
Distribution
- Quantity
- 579,456 units
- 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-0254-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.