Glenmark Mometasone Furoate Cream recalled over manufacturing violations

Recall date

November 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

D-0336-2018

FDA classification

Class II

Brand / firm

Glenmark Pharmaceuticals Inc., USA

Sold / distributed

Product was distributed throughout the United States.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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