US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 23, 2019 (7 years ago)

Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b)…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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

Recalling firm
Glenmark Pharmaceuticals Inc., USA
NDC code
68462-192-17
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1586-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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