Regenerect Recall
Regenerect: Recall - Undeclared Drug Ingredient
Ethos Environmental, Inc. Issues a VoluntaryRecall of Specific Lots of the DietarySupplement Regenerect
Companies: Ethos Environmental Inc.
Press Release
Source: Ethos Environmental, Inc.
On Thursday April 28, 2011, 6:35 pm EDT
IRVINE, Calif., April 28, 2011 -- Ethos Environmental, Inc. (Pink Sheets:ETEV ) announced today that it is conducting a voluntary nationwide recall of the company's dietary supplement sold under the brand name Regenerect with the following LotNumbers:
Regenerect LotNumbers:
100521 - blue capsule sold individually in foil packets, expires 5/2012
112850 - clear capsule sold individually in foil packets, expires11/2013
Ethos Environmental, Inc. is conducting a voluntary 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 ErectileDysfunction (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 theanalogue 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. FDA has advised thatED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
Ethos Environmental, Inc. has distributed Regenerect via sales made over the internet to consumers in the United States of America and Puerto Rico.Ethos Environmental, Inc. advises any customers in possession of the Regenerect productmatching the lot numbers above to return any unused product for an exchange, or a full refund,to the company directly. Customers can call (866) 925-9553 (Monday through Friday from 6amto 6pm Pacific Time) for instructions on the return and exchange/refund process.
Ethos Environmental, Inc. is committed to improving its products and avoiding future recall issues by improving testing procedures. Ethos Environmental, in an effort to be abundantlycautious, is issuing a voluntary recall on the two lots, mentioned above, that did not comply withthe newly adopted testing protocol of Ethos Environmental. The Company's testing protocol and test results will be available on the Company's website for all consumers. Any consumers requesting an exchange of product from the two lots in question will be receiving Regenerectproduct that has been subjected to the Company's new testing procedures. Ethos Environmental promises its customers the highest possible quality and welcomes the recall process as furtherevidence of our commitment to our brands, products and consumers.Any adverse reactions or quality problems experienced with the use of these products may bereported to the FDA's MedWatch Adverse Event Reporting program either online, by regularmail or by fax.
Online: http//:www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.