Recalls / Class I
Class ID-0250-2022
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105
- Brand name
- Tinactin
- Generic name
- Tolnaftate
- Active ingredient
- Tolnaftate
- Route
- Topical
- NDC
- 11523-4162
- FDA application
- M005
- Affected lot / code info
- Lot # TN0067A, EXP 2/28/2023; TN008CU, EXP 4/30/2023;
Why it was recalled
Chemical Contamination: presence of 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-0250-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.