Hydroxocobalamin 5000IU/mL Injection recalled over sterility concerns

Recall date

October 19, 2015

Source

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

Official notice title

Western Drug recalls Hydroxocobalamin 5000IU/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938

Recall number

D-0410-2016

FDA classification

Class II

Brand / firm

Western Drug

Sold / distributed

Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah

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

Hydroxocobalamin 5000IU/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938