Drug product
Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 NDC 68462019255 UPC 3684620192559
D-0336-2018
Product summary
- Event
- Event 78605
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5136 tubes
- Official record key
drug-enforcement:D-0336-2018
Official wording
Reason: CGMP Deviations: Market complaints related to "gritty texture".
Code information: Batch Number: 05170598; Exp. 03/19
Distribution pattern: Product was distributed throughout the United States.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations