June 2022 FDA Recall Mometasone Furoate by Glenmark Pharmaceuticals Inc., Usa
D-1173-2022 - Defective Container

This Class III drug recall was voluntarily initiated by Glenmark Pharmaceuticals Inc., Usa on June 16, 2022 for the product Mometasone Furoate. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1173-2022

Reason for Recall
Defective Container
Initiated
06-16-2022
Reported
07-13-2022
Quantity
98, 307 packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90473
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-24-2026
Product Description About Product Description
Full technical description of the product.
Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah NJ 07430.

Batch or Lot Expiration Information

Lot# a) 05201358, Exp 06/2022; 05210287, 05210288, Exp 01/2023; 05211446, Exp 07/2023; 05211704, 05211714, Exp 08/2023; 05212217, Exp 10/2023: b) 05201358, Exp 06/2022; 05210287, 05210288, 05210424, Exp 01/2023; 05210425, 05210435, Exp 02/2023; 05211427, 05211439, 05211445, Exp 07/2023; 05211723, 05211731, 05211850, 05211864, Exp 08/2023; 05212226, 05212250, 05212261, Exp 10/2023.

Affected Packages Involved in this Recall

68462-385-37 Mometasone Furoate
68462-385-02 Mometasone Furoate