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FDAFDA · Food and drugs·Recall number D-0236-2015

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

Published November 12, 2014 · Recall initiated: September 26, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Failed Dissolution Specifications; 12 month stability time point

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
Sun Pharma Global Inc.
Distributor
Nationwide and Puerto Rico
Lot
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
Risk classification
Class II
Area (FDA)
drug
Country
United Arab Emirates

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