Drug product
Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3.
D-0251-2022
Product summary
- Event
- Event 88677
- Status
- Terminated
- Classification
- Class I
- Quantity
- 4,990,860 cans
- Official record key
drug-enforcement:D-0251-2022
Official wording
Reason: Chemical Contamination: presence of benzene
Code information: Lot # (a)TN006MX, EXP 10/31/2022; TN00BKV, TN008D1, TN008D2, EXP 3/31/2023; (b) CV0180B, EXP12/31/2021; TN003C5, EXP 1/31/2023
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