What: Regenerect
Why: Contains Sulfoaildenafil, an analogue of Sildenafil, a prescription drug used in the treatment of male Erectile Dysfunction
Scope: Nationwide
Ethos Environmental is conducting a nationwide recall of the company?s dietary supplement sold under the brand name Regenerect with the following Lot Numbers:
?100521 - blue capsule sold individually in foil packets, expires 5/2012.
?112850 - clear capsule sold individually in foil packets, expires 11/2013.
Ethos Environmental is conducting the recall because FDA lab analysis has confirmed the presence of Sulfoaildenafil, an analogue of Sildenafil, making 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. Further, ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
Ethos Environmental distributed Regenerect via sales made over the internet to consumers in the United States and Puerto Rico.
Any customers in possession of the Regenerect product matching the lot numbers above are advised to return any unused product for exchange or a full refund to the company directly. Customers can call (866) 925-9553, Monday through Friday from 6 a.m. to 6 p.m. Pacific time, for instructions on the return and exchange/refund process.
Any adverse reactions experienced with the use of this product and/or quality problems should be reported to the FDA's MedWatch Program 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: MedWatch U.S. Food and Drug Administration 5600 Fishers Lane Rockville, MD 20852-9787
