Ethos Environmental, Inc. just announced a voluntary nationwide recall of its <"https://www.yourlawyer.com/practice_areas/defective_drugs">dietary supplement sold under the brand name Regenerect, the U.S. Food and Drug Administration (FDA) just announced.
The Regenerect lot numbers, descriptions, and expiration dates involved are:
• 100521: Blue capsule sold individually in foil packets; expires 5/2012
• 112850: Clear capsule sold individually in foil packets; expires 11/2013
FDA lab analysis confirmed the presence of Sulfoaildenafil, an analogue of Sildenafil, which renders these products unapproved new drugs. Sildenafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.
According to the FDA, use of these products may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. FDA has advised that consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and has also advised that ED is a common problem in men with these conditions; consumers may seek these types of products to enhance sexual performance.
Ethos Environmental, Inc. distributed Regenerect via sales made over the Internet to consumers in the United States and Puerto Rico and is now advising any customers in possession of the Regenerect product matching the lot numbers above to return that unused product to the company directly for an exchange or a full refund. Customers can reach the firm, toll-free, at 1.866.925.9553, Monday through Friday, from 6:00 a.m. to 6:00 p.m. Pacific Time to receive return and exchange/refund process instructions.
Consumers requesting an exchange of recalled product from the two lots in question will receive a Regenerect product that was tested under the firm’s new testing procedures, the FDA said.
Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Online: http://www.fda.gov/MedWatch/report.htm; Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form; or Fax: 1-800-FDA-0178.
