drugs Class II Updated 2014-03-12

Teva Pharmaceuticals USA recalls Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dex

Recalled Product

Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts) , 100 count-bottle, Rx Only, Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0972-02.

Hazard / Issue

CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # 34017575A, Exp. 10/16.
View official government recall

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