drugs Class II Updated 2015-02-18

AnazaoHealth Corporation recalls Compounded Plaquex, intravenous injection, 50 ML vial. Eac

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 112614-1MC-82186 Exp 5/26/2015; 112614-1MC-82187 Exp 5/26/2015; 112614-1MC-82188 Exp 05/26/205 ;112614-1MC-82189 Exp 5/26/2015
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