FDA-Drug2015-02-18Class II
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.
AnazaoHealth Corporation
Hazard
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Sold states
Nationwide
Affected count
51 vials
Manufactured in
7465 W Sunset Rd Ste 1200, N/A, Las Vegas, NV, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D0384-2015Don't want to check this manually?
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