FDA-Drug2019-08-14Class II
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
Glenmark Pharmaceuticals Inc., USA
Hazard
GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
Sold states
Nationwide within the United States
Affected count
N/A
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1586-2019Don't want to check this manually?
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