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.

Recall Number: D0384-2015

Firm: AnazaoHealth Corporation

Classification: Class II

Status: Terminated

Report Date: 20150218

Initiation Date: 20150126

Termination Date: 20150209

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

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.