February 14, 2012
Regeneca, Inc. Recalls a Specific Lot of RegenArouse
The Missouri Department of Health and Senior Services received the following recall regarding RegenArouse, Lot Number 130100, because of the presence of Tadalafil making these products unapproved new drugs. Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction. The active drug ingredient is not listed on the label for these products.
RegenArouse, Lot Number 130100, is a pink capsule sold individually in foil packets, with the expiration date of 12/5/2013 and a UPC code of 816860010079.
Use of these products may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Regeneca, Inc. has distributed RegenArouse via sales made over the internet to consumers in the United States of America and Puerto Rico between November 29, 2011 and February 10, 2012.
The full recall announcement can be found at: www.fda.gov/Safety/Recalls/ucm291546.htm?source=govdelivery.