Texas-based, U.S. Good Health Inc. has issued a voluntary, nationwide recall of the dietary supplement Vialipro, which is sold in 10-capsule packages and can be used for sexual enhancement, according to a press release from V.I. Department of Health.
The company issued the voluntary recall of the supplement after it learned from the Food and Drug Administration (FDA) that lab analysis found it contained Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male erectile dysfunction (ED). The active drug ingredient is not listed on the dietary supplement, and the undeclared ingredient may pose a threat to consumers because the interaction with some prescription drugs may lower blood pressure to dangerous levels, according to the FDA.
Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs and the FDA said that erectile dysfunction is a common problem in men with these conditions and that they may seek these products to enhance sexual performance.
“We urge consumers who may have purchased Vialipro to discontinue its use,” Commissioner of Health Julia Sheen said. “The product will be refunded by the company.”
Customers can call (866) 607-0338 Monday through Friday from 9 a.m. to 5 p.m. to learn more about the refund process. Meanwhile, distributors are advised to stop selling Vialipro and to also contact the company for instructions.
Sheen said that it was the second time in three months the DOH has had to issue a warning to consumers about dietary supplements containing an unapproved drug. In April, the Environmental Health staff pulled VIM-25, a single-dose purple pill, off store shelves after the department learned from the FDA that it contained Tadalafil, the active ingredient in the FDA approved drug Cialis, which is commonly prescribed for the treatment of erectile dysfunction.
DOH epidemiologist Dr. Eugene Tull said that routine visits to stores will be conducted to ensure that owners are adhering to the notice to cease such sales.