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Recall Observatory FDA recall evidence

Drug 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.

D0384-2015

January 26, 2015

Class II

Product summary

Firm
AnazaoHealth Corporation
Event
Event 70465
Status
Terminated
Classification
Class II
Quantity
51 vials
Official record key
drug-enforcement:D0384-2015

Official wording

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

Code information: 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

Distribution pattern: Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Good Manufacturing Practices Deviations