Product: 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.
Reason for recall: Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Recall initiated: 20150126
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated