D-0336-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 7, 2018
- Initiation Date
- November 20, 2017
- Termination Date
- October 3, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5136 tubes
Product Description
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
Reason for Recall
CGMP Deviations: Market complaints related to "gritty texture".
Distribution Pattern
Product was distributed throughout the United States.
Code Information
Batch Number: 05170598; Exp. 03/19