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.

Recall Insight

This FDA Drug action (record #D0384-2015) was formally reported on February 18, 2015, with the manufacturer initiating the action on January 26, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. AnazaoHealth Corporation is listed as the recalling firm, operating out of Las Vegas, NV. Federal records indicate 51 vials units are affected.

The documented reason for this recall is: Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source. Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.