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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Product Detail

Product Description Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories Limited, Batchupally - 500 090 India. NDC55111-466-01
Recall Number D-1381-2014
Classification Class II
Code Info Lot # C206578 Exp. 05/14 Lot # C207415 Exp. 06/14
Product Distributed Qty 13560 bottles
Reason For Recall Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.

Event Detail

Event Id 68513
Product Type Drugs
Status Ongoing
Recalling Firm Dr. Reddy's Laboratories, Inc.
City Princeton
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-23
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide