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U.S. Department of Health and Human Services

Enforcement Report - Week of August 27, 2014

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Product Detail

Product Description Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA
Recall Number D-1541-2014
Classification Class II
Code Info Lot # a) LN11005, Exp 04/15; LN11006; Exp 04/15; b) LN10979; Exp. 04/15, LN10980; Exp. 04/15
Product Distributed Qty 11,661 HDPE bottles
Reason For Recall Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.

Event Detail

Event Id 68941
Product Type Drugs
Status Ongoing
Recalling Firm Wockhardt Usa Inc.
City Parsippany
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-07-24
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide