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
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.
Classification
Class II
Status
Terminated
Lot
Lot #: 100023340, Exp 10/2024
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Teva Pharmaceuticals USA Inc — Class II Recall | MedicineWatch US