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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Lot C203090 Exp.03/14 Class II 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. 1512 bottles D-059-2013
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