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Glenmark Pharmaceuticals Inc., USA recalls Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manuf

Recalled February 7, 2018 · FDA recall D-0336-2018 · Glenmark Pharmaceuticals Inc., USA

Hazard
CGMP Deviations: Market complaints related to "gritty texture". · FDA Class II
Units
5136 tubes
Sold at
Product was distributed throughout the United States.

Description

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

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
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov