FDA recall D-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

Reason for recall

CGMP Deviations: Market complaints related to "gritty texture".

Distribution

Product was distributed throughout the United States.

Key facts

Status

Terminated

Initiation date

2017-11-20

Report date

2018-02-07

Termination date

2018-10-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0336-2018