HydrALAZINE HYDROCHLORIDE INJECTION recalled over temperature-control failures

Recall date

March 8, 2017

Source

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

Official notice title

Mckesson Medical Surgical recalls hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, AP…

Recall number

D-0668-2017

FDA classification

Class II

Brand / firm

Mckesson Medical Surgical

Sold / distributed

Nationwide in the USA

Why it was recalled

Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. were inadvertently stored refrigerated rather than the labeled room temperature recommendation.

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

What was recalled

hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, packaged in 25 Vials per carton, Rx only, APP Fresenius Kabi USA, LLC, Lake Surich, IL 60047, NDC 63323-614-01, Distributed by McKesson Medical-Surgical, Inc.