September 2014 FDA Recall Drug by Sun Pharma Global Inc.
D-0236-2015 - Failed Dissolution Specifications; 12 month stability time point

This Class II drug recall was voluntarily initiated by Sun Pharma Global Inc. on September 26, 2014 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications; 12 month stability time point. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0236-2015

Reason for Recall
Failed Dissolution Specifications; 12 month stability time point
Initiated
09-26-2014
Reported
11-12-2014
Quantity
68194

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69370
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.
Sun Pharma Global Inc.
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-06-2015
Product Description About Product Description
Full technical description of the product.
Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma Global Inc. Dubai, United Arab Emirates by Sun Pharmaceutical Industries Limited, Halol, India

Batch or Lot Expiration Information

Batch# Batch Number: JKM3855A Mfg. Date: 06/25/2013 Exp. Date: 05/31/2015 Batch Number: JKM3855B Mfg. Date: 06/25/2013 Exp. Date: 05/31/2015 Batch Number: JKM7265A Mfg. Date: 12/25/2013 Exp. Date: 11/30/2015 Batch Number: JKM7265B Mfg. Date: 12/25/2013 Exp. Date: 11/30/2015