PARAMOUNT, Calif. — AVNS Inc. announced Tuesday that it is voluntarily recalling The Best Enhancement Supplement.
AVNS Inc. is conducting a voluntary recall after being informed by its manufacturer, Drive Total Energy, that the Food and Drug Administration (FDA) lab analyses found the products to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs. The active drug ingredient is not listed on the product label.
The undeclared ingredient may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels, the company said. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs. Erectile Dysfunction is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
To date, AVNS Inc. and Drive Total Energy are not aware of any reports made to the FDA concerning any adverse effects associated with the use of The Best. In addition, Drive Total Energy and AVNS currently have not received any complaints from its customers. Out of an abundance of caution and concern for the health and welfare of its customers, AVNS is voluntarily notifying our customers of the FDA’s findings.
"We urge consumers who have purchased these products to discontinue their use and return the products to their place of purchase for a full refund," AVNS said in a press release announcing the recall.
Customers with questions can call or email AVNS at email@example.com PST Monday through Friday from 9 a.m. – 4 p.m. for instructions on the return process.
It is the position of AVNS that it did not in any way knowingly or intentionally violate the law with regard to the distribution of these products, the company said.
Adverse reaction or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax.
Online: www.fda.gov/MedWatch/report.htm. Regular mail: use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm10.
Mail to address on the pre-addressed form; fax: 1-800-FDA-0178.