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U.S. Department of Health and Human Services

Enforcement Report - Week of July 2, 2014

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Product Detail

Product Description Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.
Recall Number D-1408-2014
Classification Class II
Code Info Lot # 34013122A, Exp 11/15
Product Distributed Qty 9,882 bottles
Reason For Recall Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.

Event Detail

Event Id 68225
Product Type Drugs
Status Ongoing
Recalling Firm Teva Pharmaceuticals USA
City Horsham
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-01
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico