Glenmark Pharmaceuticals Inc., USA recalls Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-…

Recall date

July 23, 2019

Source

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

Recall number

D-1586-2019

FDA classification

Class II

Brand / firm

Glenmark Pharmaceuticals Inc., USA

Sold / distributed

Nationwide within the United States

Why it was recalled

GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.

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

What was recalled

Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Manufactured by; Glenmark Pharmaceuticals Ltd At: Village: Kishanpura, Baddi Nalagari Road, District: Solan, Himachal Pradesh -173205, India Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430