Drug 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.
D-1539-2022
Product summary
- Event
- Event 90803
- Status
- Terminated
- Classification
- Class II
- Quantity
- 83,703 bottles
- Official record key
drug-enforcement:D-1539-2022
Official wording
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.
Code information: Lot #: 100023340, Exp 10/2024
Distribution pattern: Nationwide in the US.
Derived failure modes
-
Labeling or packaging
Labeling: Label Error