Drug recall D-1539-2022
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.
Reason for recall
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.
Lots and codes
Lot #: 100023340, Exp 10/2024
Recall details
- Recalling firm
- Teva Pharmaceuticals USA Inc, Parsippany, NJ
- Quantity
- 83,703 bottles
- Distribution
- Nationwide in the US.
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 29, 2022
- Terminated
- August 14, 2023
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.