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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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Event Detail

Event ID 67933
Product Type Drugs
Status Ongoing
Recalling Firm Wockhardt Usa Inc.
City Parsippany
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-01
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1. Lot #: LN10686, LN10687, LN10688, LN10707, LN10708, Exp 02/15 Class II Failed Dissolution Specifications: failure of dissolution test observed at nine month time point. 109,744 bottles D-1300-2014
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