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
Product summary
- 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
CGMP Deviations