AVNS Recalls Rock Hard Extreme and Best Male Enhancer
By: Andy Powell, Staff Writer
PARAMOUNT, CA — AVNS inc Distribution announced Tuesday March 29th, that they are voluntarily recalling The Best Enhancer and the Rock Hard Extreme Male Enhancement supplements .
AVNS Inc. is conducting a voluntary recall after being informed by their 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.
Neither AVNS Inc. Distribution or Drive Total Energy were aware of any reports made to the FDA concerning any adverse effects associated with the use of The Best. Furthermore Drive Total Energy and AVNS inc Distribution currently have not received any complaints from their customer base. Out of an abundance of caution and concern for the health and welfare of their vendors and customers, AVNS inc Distribution is voluntarily notifying their 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.
Retailers and wholesale distributors with questions can email AVNS at email@example.com or call 1-562-602-6515 Monday through Friday from 9 a.m. – 4 p.m. PST for instructions on the return process.
It is the position of AVNS inc Distribution 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 via facsimile.
Mail to address on the pre-addressed form
You can also facsimile your concerns to: 1-800-FDA-0178.