Recalls / Class II
Class IID-0336-2018
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
- Affected lot / code info
- Batch Number: 05170598; Exp. 03/19
Why it was recalled
CGMP Deviations: Market complaints related to "gritty texture".
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 5136 tubes
- Distribution pattern
- Product was distributed throughout the United States.
Timeline
- Recall initiated
- 2017-11-20
- FDA classified
- 2018-02-07
- Posted by FDA
- 2018-02-07
- Terminated
- 2018-10-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0336-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.