Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceutic...
FDA Recall #D-0336-2018 — Class II — November 20, 2017
Product Description
Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 NDC 68462019255 UPC 3684620192559
Reason for Recall
CGMP Deviations: Market complaints related to "gritty texture".
Recalling Firm
Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5136 tubes
Distribution
Product was distributed throughout the United States.
Code Information
Batch Number: 05170598; Exp. 03/19
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated