Drug product
LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8
D-0247-2022
Product summary
- Event
- Event 88677
- Status
- Terminated
- Classification
- Class I
- Quantity
- 4,546,152 cans
- Official record key
drug-enforcement:D-0247-2022
Official wording
Reason: Chemical Contamination: presence of benzene
Code information: Lot # CV018TV, 11/30/2021; CV01A71, 1/31/2022; CV01CK4, 4/30/2022; TN0023G, 12/31/2022; TN006TC, 1/31/2023; TN007TG, 3/31/2023; TN008CZ, 4/30/2023; TN008CY, 4/30/2023.
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