Class II
Terminated
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.
- Company
- Teva Pharmaceuticals Usa, Inc
- Recall Initiated
- August 29, 2022
- Posted
- September 21, 2022
- Recall Number
- D-1539-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 83,703 bottles
- Firm Location
- Parsippany, NJ, United States
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.
Distribution
Nationwide in the US.
Lot / Code Info
Lot #: 100023340, Exp 10/2024
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