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Recall Observatory FDA recall evidence

Drug 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.

D-1094-2014

January 24, 2014

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 67412
Status
Terminated
Classification
Class II
Quantity
9796 tablets
Official record key
drug-enforcement:D-1094-2014

Official wording

Reason: 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.

Code information: Lot # 34017575A, Exp. 10/16.

Distribution pattern: Nationwide.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations