FDA-Drug2018-02-07Class II

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

Glenmark Pharmaceuticals Inc., USA
Hazard

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

Sold states
Product was distributed throughout the United States.
Affected count
5136 tubes
Manufactured in
750 Corporate Dr, Mahwah, NJ, United States
Products
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

Official notice

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

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