Recall Enforment Report D-1539-2022
Recall Details
Drug Recall Enforcement Report Class II voluntary initiated by Teva Pharmaceuticals USA Inc, originally initiated on 08-29-2022 for the product Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, Rx Only, 100 tablets per bottle, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0555-0777-02. The product was recalled due to labeling: label error on declared strength; a sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.. 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 |