Recall Enforment Report D-0050-2015
Recall Details
Drug Recall Enforcement Report Class II voluntary initiated by Teva Pharmaceuticals USA, originally initiated on 10-08-2014 for the product DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bottles, Rx Only. Teva Pharmaceuticals USA , Sellersville, PA 18960, NDC: 0555-0972-02. 0555-0972-02, lot #s 34016373A, 34016377A, exp. dated 7/2016. The product was recalled due to failed impurities/degradation specifications: out of specification for unknown impurities.. The product was distributed nationwide and the recall is currently terminated.
Recalled Products
NDC | Proprietary Name | Non-Proprietary Name | Dosage Form | Route Name | Company Name | Product Type |
---|---|---|---|---|---|---|
0555-0775 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Tablet | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0555-0776 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Tablet | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0555-0777 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Tablet | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0555-0971 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Tablet | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0555-0972 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Tablet | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0555-0973 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Tablet | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |
0555-0974 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Tablet | Oral | Teva Pharmaceuticals Usa, Inc. | Human Prescription Drug |