Actavis Elizabeth LLC recalls Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg,…

Recall date

February 16, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0813-2016

FDA classification

Class II

Brand / firm

Actavis Elizabeth LLC

Sold / distributed

US: Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications: Out of specification for impurities.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-745-11.