AnazaoHealth Corporation recalls Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxychola
Recalled February 18, 2015 · FDA recall D0384-2015 · AnazaoHealth
Hazard
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source. · FDA Class II
Units
51 vials
Sold at
Nationwide
Description
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
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.
Manufacturer(s)
AnazaoHealth Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →