AVNS Inc. just announced that is recalling its <"https://www.yourlawyer.com/practice_areas/defective_drugs">“The Best†Enhancement Supplement, according to the U.S. Food and Drug Administration (FDA).
AVNS initiated the recall after being informed by its manufacturer, Drive Total Energy, that an FDA lab analyses found that the products contain Sulfoaildenafil. Sulfoaildenafil is an analogue of Sildenafil, an FDA-approved drug that is used in the treatment of male Erectile Dysfunction (ED). The unauthorized use of Sildenafil in the supplement product makes that product an unapproved new drug.
AVNS claims it did not in any way knowingly or intentionally violate the law concerning distribution of the defective, unauthorized products. The FDA notes that 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. ED 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 and Drive Total Energy and AVNS have not received any complaints from its customers. AVNS is voluntarily notifying its customers of the FDA’s findings.
The FDA is urging consumers who have purchased these products to discontinue their use and return the products to their place of purchase for a full refund.
AVNS can be reached by telephone at 1.562.602.6515 or by email at avnsinc@aol.com. AVNS is available, Pacific Coast Time (PST), from Monday through Friday, 9:00 a.m. to 4:00 p.m., 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 regular mail, or by fax: Online: www.fda.gov/MedWatch/report.htm; by Regular Mail, use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form; or by fax to 1.800.FDA.0178.
