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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Detail

Product Description Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05
Recall Number D-059-2013
Classification Class II
Code Info Lot C203090 Exp.03/14
Product Distributed Qty 1512 bottles
Reason For Recall Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.

Event Detail

Event Id 63524
Product Type Drugs
Status Ongoing
Recalling Firm Dr. Reddy's Laboratories, Inc.
City Bridgewater
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-27
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide. No foreign consignees.