FDAJanuary 26, 2015drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

anazaohealth

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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