Drug & medication recalls Moderate risk

HYDROXYZINE HYDROCHLORIDE 25MG/ML INJECTABLE recalled over sterility concerns

Recall date
May 18, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Advanced Physician Solutions, Inc. recalls HYDROXYZINE HYDROCHLORIDE (STERILE WATER) (10ML VIAL) 25MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Av…
Recall number
D-1100-2015
FDA classification
Class II
Brand / firm
Advanced Physician Solutions, Inc.
Sold / distributed
Nationwide

Why it was recalled

Lack of Assurance of Sterility

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 (STERILE WATER) (10ML VIAL) 25MG/ML INJECTABLE, Advanced Compounding Pharmacy, 7225 Fulton Ave., North Hollywood, CA 91605

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