FDA recall D-1586-2019

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

Reason for recall

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

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2019-07-23

Report date

2019-08-14

Termination date

2021-10-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1586-2019