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U.S. Department of Health and Human Services

Enforcement Report - Week of November 12, 2014

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Product Detail

Product Description 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
Recall Number D-0236-2015
Classification Class II
Code Info 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
Product Distributed Qty 68194
Reason For Recall Failed Dissolution Specification; 12 month stability timepoint

Event Detail

Event Id 69370
Product Type Drugs
Status Ongoing
Recalling Firm Sun Pharma Global Inc.
City Dubai
State
Country AE
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-09-26
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide and Puerto Rico
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