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 68462-192-5
Recalled August 14, 2019 · FDA recall D-1586-2019 · Glenmark Pharmaceuticals Inc., USA
Hazard
GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty. · FDA Class II
Units
N/A
Sold at
Nationwide within the United States
Description
GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
Product
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
Manufacturer(s)
Glenmark Pharmaceuticals Inc., USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →