Supplement containing unlisted ED drug is recalled by manufacturer

March 1, 2007

The manufacturer of a sexual performance-enhancing supplement has announced a voluntary recall of the product, known as Liviro3. FDA lab analysis found the product contains the erectile dysfunction drug tadalafil, making Liviro3 an unapproved drug.

The manufacturer of a sexual performance-enhancing supplement has announced a voluntary recall of the product, known as Liviro3. FDA lab analysis found the product contains the erectile dysfunction drug tadalafil, making Liviro3 an unapproved drug.

During the voluntary recall process, the manufacturer discovered a counterfeit of its product on the market. Both Liviro3 and the counterfeit supplement are undergoing renewed independent testing.

A bulletin issued by FDA cautions consumers who have either the genuine or counterfeit product in their possession to stop using it immediately and to contact their physician if they have experienced any problem that may be related to using either product.

Serious adverse events stemming from the use of Ebek’s Liviro3 or counterfeit Liviro3 should be reported to FDA’s MedWatch Adverse Event Reporting program online (www.fda.gov/MedWatch/report.htm) or by calling 800-FDA-1088.