Drug product
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a) single pack, UPC 0 41100 58720 6, NDC 11523-0010-2; (b) 3-pack, UPC 0 41100 58961 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland,
D-0240-2022
Product summary
- Event
- Event 88677
- Status
- Terminated
- Classification
- Class II
- Quantity
- 579,456 cans
- Official record key
drug-enforcement:D-0240-2022
Official wording
Reason: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Code information: Lot # (a)TN0023C, EXP 1/31/2022; TN003C7, EXP 4/30/2022; TN00570, EXP 7/31/2022; TN0056Z, TN005KJ, EXP 8/31/2022; (b)TN0023C, EXP 01/31/2022; TN003C7, EXP 04/30/2022; TN0023DV, TN0023DAV, TN0023DBV, TN0023DC, EXP 02/28/2022; TN005KJ, TN005KJA, TN005KJB, EXP 08/31/2022;
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