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U.S. Department of Health and Human Services

Enforcement Report - Week of January 20, 2016

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Product Detail

Product Description DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0.
Recall Number D-0566-2016
Classification Class II
Code Info Lot #: 34015516A, Exp 05/16
Product Distributed Qty 9,717 bottles
Reason For Recall Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.

Event Detail

Event Id 72988
Product Type Drugs
Status Ongoing
Recalling Firm Teva Pharmaceuticals USA
City North Wales
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2015-11-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide