FDA posts press releases and other
notices of recalls and market withdrawals from the firms involved
as a service to consumers, the media, and other interested parties.
FDA does not endorse either the product or the company.
Contact:
800-690-6958
FOR IMMEDIATE RELEASE - February
10, 2012 - Regeneca, Inc. announced today that it is conducting a
voluntary nationwide recall of RegenArouse, Lot Number 130100,
because FDA lab analysis has confirmed the presence of Tadalafil
making these products unapproved new drugs. Tadalafil 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.
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.
FDA has advised that consumers with diabetes, high blood pressure,
high cholesterol, or heart disease often take nitrates. FDA has
advised that ED is a common problem in men with these conditions,
and consumers may seek these types of products to enhance sexual
performance.
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.
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. Regeneca, Inc. had this specific
lot of RegenArouse capsules tested at a testing facility and had
received a report indicating that no PDE-5 inhibitors or any of
their analogues were detected in the capsules. The Company learned
today that there was an error on this test and has thus made the
decision to issue a voluntary nationwide recall on this lot of
RegenArouse. Regeneca, Inc. is committed to improving its products
and avoiding future recall issues by improving its existing testing
procedures.
Regeneca, Inc. advises any customers in possession of the
RegenArouse product matching the lot number above to return any
unused product for an exchange, or a full refund, to the company
directly. Customers can call (800) 690-6958 (Monday through Friday
from 8am to 6pm Pacific Time) for instructions on the return and
exchange/refund process.
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.
This recall is being conducted with the knowledge of the U.S.
Food and Drug Administration.
##