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AVNS Inc. Issues Voluntary Recall of The Best Enhancer

samsung1

Ohio

Manufacturer failed to list ingredient on product label

Posted Mar 29th, 2011 11:41 AM
PARAMOUNT, Calif.—AVNS Inc. announced today 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 that 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. 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 their customers, AVNS is voluntarily notifying our customers of the FDA's findings.

Consumers who have purchased these products should discontinue their use and return the products to their place of purchase for a full refund.

Customers with questions can call or AVNS at (562) 602-6515 or email [email protected] for instructions on the return process.

It is the position of AVNS that the company did not in any way knowingly or intentionally violate the law with regard to the distribution of these products.

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: (800) FDA-0178.)
http://business.avn.com/articles/novelty…