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-0237-2022
Product summary
- Event
- Event 88677
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,546,152 cans
- Official record key
drug-enforcement:D-0237-2022
Official wording
Reason: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Code information: Lot #: CV01BEP, 3/31/2022; CV01D6W, 5/31/2022; CV01EV0, 7/31/2022; TN0004J, 9/30/2022; TN001AE, 11/30/2022; TN003C3, 1/31/2023; TN003C4, 2/28/2023; TN003HT, 3/31/2023; TN003CW, 4/30/2023; TN0045J, 6/30/2023; TN0040C, 7/31/2023; TN004BU, 8/31/2023; TN006MB, 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