FDA Recall Terminated Historical recordClass 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
- Reason
- GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
- Published
- August 14, 2019
- Distribution
- Nationwide
