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U.S. Department of Health and Human Services

Enforcement Report - Week of June 24, 2015

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Product Detail

Product Description Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01
Recall Number D-1136-2015
Classification Class II
Code Info Lot #C308195, exp 10/2015
Product Distributed Qty
Reason For Recall Failed Dissolution Specifications; exceeded specification at the 9 hour time point

Event Detail

Event Id 71374
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 2015-05-22
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide
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