Drug product
LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7
D-0248-2022
Product summary
- Event
- Event 88677
- Status
- Terminated
- Classification
- Class I
- Quantity
- 3,816,468 cans
- Official record key
drug-enforcement:D-0248-2022
Official wording
Reason: Chemical Contamination: presence of benzene
Code information: Lot # CV01AP2, EXP 2/28/2022; TN006TD, EXP 3/31/2023; TN008CV, EXP 4/30/2023; TN008CW, EXP 5/31/2023;
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