FDA 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.

Distribution

Nationwide in the US.

Key facts

Status

Terminated

Initiation date

2022-08-29

Report date

2022-09-21

Termination date

2023-08-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1539-2022