November 2017 FDA Recall Drug by Glenmark Pharmaceuticals Inc., Usa
D-0336-2018 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Glenmark Pharmaceuticals Inc., Usa on November 20, 2017 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed throughout the United States. and the recall is currently terminated.

Recall Number: D-0336-2018

Reason for Recall
CGMP Deviations: Market complaints related to "gritty texture".
Initiated
11-20-2017
Reported
02-07-2018
Quantity
5136 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78605
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-03-2018
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Batch# Batch Number: 05170598; Exp. 03/19