Recalls / Class II
Class IID-0242-2022
Product
Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of Finland 86568411; (b) UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981
- Brand name
- Tinactin
- Generic name
- Tolnaftate
- Active ingredient
- Tolnaftate
- Route
- Topical
- NDC
- 11523-4162
- FDA application
- M005
- Affected lot / code info
- Lot # (a) TN004BW, EXP 7/31/2022, (b) TN00678, EXP 8/31/2022; TN00679, EXP 9/30/2022;
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.
- 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
- 738,432 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-0242-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.