Akorn, Inc. recalls Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Ph…

Recall date

April 7, 2015

Source

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

Recall number

D-1130-2015

FDA classification

Class II

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide including Puerto Rico

Why it was recalled

Failed Impurities/Degradation 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

Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16