Drug & medication recalls Moderate risk

Actavis Elizabeth LLC recalls Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabe…

Recall date
February 10, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0395-2015
FDA classification
Class II
Brand / firm
Actavis Elizabeth LLC
Sold / distributed
Nationwide

Why it was recalled

Failed Dissolution Specifications

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 Sulfate Extended-Release Capsules, 15 mg, 90-count bottles, Rx Only, Manufactured by: Actavis Elizabeth LLC, Elizabeth, NJ 07201 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 45963-305-09, UPC 3 45963-305-09 1.

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