Compounded Plaquex recalled over manufacturing violations

Recall date

January 26, 2015

Source

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

Official notice title

AnazaoHealth Corporation recalls Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholat…

Recall number

D0384-2015

FDA classification

Class II

Brand / firm

AnazaoHealth Corporation

Sold / distributed

Nationwide

Why it was recalled

Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

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

What was recalled

Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection.