Drug recall D-0566-2016
Product
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.
Reason for recall
Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.
Lots and codes
Lot #: 34015516A, Exp 05/16
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, North Wales, PA
- Quantity
- 9,717 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 12, 2015
- Terminated
- November 1, 2016
Related products
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate – drug information
- NDC 0555-0973 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate · Dextroamphetamine Saccharate 5 mg/1; Amphetamine Aspartate… · Teva Pharmaceuticals USA, Inc.
- NDC 0555-0776 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate · Dextroamphetamine Saccharate 3.125 mg/1; Amphetamine… · Teva Pharmaceuticals USA, Inc.
- NDC 0555-0775 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate · Dextroamphetamine Saccharate 1.875 mg/1; Amphetamine… · Teva Pharmaceuticals USA, Inc.
- NDC 0555-0777 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate · Dextroamphetamine Saccharate 3.75 mg/1; Amphetamine… · Teva Pharmaceuticals USA, Inc.
- NDC 0555-0971 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate · Dextroamphetamine Saccharate 1.25 mg/1; Amphetamine… · Teva Pharmaceuticals USA, Inc.
- NDC 0555-0974 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate · Dextroamphetamine Saccharate 7.5 mg/1; Amphetamine… · Teva Pharmaceuticals USA, Inc.
- NDC 0555-0972 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate · Dextroamphetamine Saccharate 2.5 mg/1; Amphetamine… · Teva Pharmaceuticals USA, Inc.