Drug 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
D-0242-2022
Product summary
- Event
- Event 88677
- Status
- Terminated
- Classification
- Class II
- Quantity
- 738,432 cans
- Official record key
drug-enforcement:D-0242-2022
Official wording
Reason: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Code information: Lot # (a) TN004BW, EXP 7/31/2022, (b) TN00678, EXP 8/31/2022; TN00679, EXP 9/30/2022;
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
contaminated with benzene
-
Manufacturing or process control
cGMP Deviations