FDA-Drug2022-09-21Class II
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.
Teva Pharmaceuticals USA Inc
Hazard
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.
Sold states
Nationwide in the US.
Affected count
83,703 bottles
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1539-2022Don't want to check this manually?
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