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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

Product Description IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. Reddy's Laboratories, Inc., Bridgewater, NJ 08807 USA.
Recall Number D-1042-2013
Classification Class II
Code Info Lot # L300192; Exp. 05/2017
Product Distributed Qty 18852 bottles
Reason For Recall Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.

Event Detail

Event Id 66117
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 2013-08-29
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide (& Puerto Rico)