The Best Sexual Enhancer Recall
|Date:||March 28, 2011|
|What:||The Best Sexual Enhancer|
|Why:||Contains Sulfoaildenafil, an analogue of Sildenafil, a prescription drug used to treat male Erectile Dysfunction|
AVNS is recalling THE BEST Sexual Enhancer Supplement. AVNS is conducting this recall after being informed by their 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.
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 it's customers.
AVNS urges consumers who purchased this product to discontinue their use and return the products to their place of purchase for a full refund.
Customers with questions can call AVNS at (562) 602-6515, Monday - Friday, 9 a.m. - 4 p.m. Pacific time or email the company at firstname.lastname@example.org for instructions on the return process.
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:
- Online: www.fda.gov/medwatch/report.htm
- Fax: 800-FDA-0178
- Phone: 800-FDA-1088
- Regular Mail: use postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm and mail to:
5600 Fishers Lane
Rockville, MD 20852-9787
Consumers with questions about food safety can Ask Heidi, a certified food safety professional.