Recall: D-1586-2019

Class II - Potentially Harmful

Class IIClassification

2019-07-23Initiated

TerminatedStatus

Glenmark Pharmaceuticals Inc.,Firm

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

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

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.