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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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Product Detail

Product Description 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.
Recall Number D-1300-2014
Classification Class II
Code Info Lot #: LN10686, LN10687, LN10688, LN10707, LN10708, Exp 02/15
Product Distributed Qty 109,744 bottles
Reason For Recall Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.

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