Drug 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.
D-0253-2022
Product summary
- Event
- Event 88677
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2,841,012 cans
- Official record key
drug-enforcement:D-0253-2022
Official wording
Reason: Chemical Contamination: presence of benzene
Code information: Lot # (a)CV015YS, EXP 9/30/2021 (b) TN008CT, TN007TJ, EXP 3/31/2023
Distribution pattern: Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels.
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination