August 2019 FDA Recall Clotrimazole And Betamethasone Dipropionate by Glenmark Pharmaceuticals Inc., Usa
D-1743-2019 - Temperature Abuse

This Class III drug recall was voluntarily initiated by Glenmark Pharmaceuticals Inc., Usa on August 7, 2019 for the product Clotrimazole And Betamethasone Dipropionate. The FDA reported the reason for recall as temperature abuse. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1743-2019

Reason for Recall
Temperature Abuse: Complaints received of liquidy texture.
Initiated
08-07-2019
Reported
08-21-2019
Quantity
31,224 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83526
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 with the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-09-2020
Product Description About Product Description
Full technical description of the product.
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tubes, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Village: Kishanpura, Baddi Nalagarth Road, District: Solan, Himachal Pradesh-173205, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-298-17

Batch or Lot Expiration Information

Lot# : 05180734, Exp. 03/2020

Affected Packages Involved in this Recall

68462-298-17 Clotrimazole And Betamethasone Dipropionate
68462-298-55 Clotrimazole And Betamethasone Dipropionate