Recalls / Class I
Class ID-0253-2022
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%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of Finland 20006106; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.
- Affected lot / code info
- Lot # (a)CV015YS, EXP 9/30/2021 (b) TN008CT, TN007TJ, EXP 3/31/2023
Why it was recalled
Chemical Contamination: presence of 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
- 2,841,012 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-0253-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.