Regenerect: Recall - Undeclared Drug Ingredient
[UPDATED 02/27/2012] Regeneca, Inc. (formeraly Ethos Environmental, Inc.) notifed the public of a nationwide recall of all lots of single-capsule packet RegenErect. Lab analysis confirmed the presence of Tadalafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making this product an unapproved new drug. RegenErect is a blue capsule sold individually in foil packets with a UPC code of 816860010055. RegenErect was distributed via sales made over the internet to consumers in the United States of America and Puerto Rico, and given as samples at public events.
ISSUE: FDA lab analysis confirmed the presence of Sulfoaildenafil, an analogue of the active ingredient of an FDA-approved drug used to treat erectile dysfunction (ED), making Regenerect an unapproved drug. The product poses a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance.
BACKGROUND: Ethos Environmental, Inc. distributed Regenerect via sales made over the internet to consumers in the United States of America and Puerto Rico. See the Press Release for specific lot numbers affected by this recall.
RECOMMENDATION: Customers in possession of the Regenerect product matching the affected lot numbers should return any unused product for an exchange, or a full refund, to the company directly.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178