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 Person:
Alex Treynker
(954) 570-6662
FOR IMMEDIATE RELEASE — March 30, 2010 –
Natural Wellness is warning consumers not to purchase or consume
the product known as MasXtreme, Lot# 911035. This product which is
being marketed as a dietary supplement contains undeclared amounts
of Aildenafil, as well as the drug Phentolamine which is an
alpha-adrenergic blocker. Aildenafil is close in structure to
Sildenafil and is expected to possess a similar pharmacological and
adverse event profile. Sildenafil is the active pharmaceutical
ingredient in an FDA-approved drug that is used to treat erectile
dysfunction (ED). This may pose a threat to consumers because
Aildenafil 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. Common side
effects of Phentolamine include arrhythmia (abnormal heart rhythm)
and tachycardia (rapid heart beat).
MasXtreme is sold in blister packs containing one (1) capsule.
The product is distributed Nationwide by Natural Wellness Inc. This
product is being promoted for increasing desire and sexual
performance. The product is sold without medical prescription.
Consumers who have purchased MasXtreme tablets are urged to
immediately discontinue their use and return the product to their
place of purchase or directly to Natural Wellness Inc. at 440 S
Federal Hwy, Suite 107, Deerfield Beach, FL 33441. Consumers with
questions regarding this recall may contact the company at
954-570-6662 Monday through Friday 8 am to 4 pm. Consumers who have
purchased this product and have medical concerns should consult
with their health care providers.
Adverse reaction or quality problems experienced with the use of
this product may be reported to the FDA’s MedWatch Adverse Event
Reporting program online, by regular mail, or by fax. Online: www.fda.gov/MedWatch/report.htm.
Regular Mail: use postage-paid, pre-addressed Form FDA 3500
available at
www.fda.gov/MedWatch/getforms.htm. Mail to address on the
pre-addressed form. Fax: 1-800-FDA-0178.
This recall is being conducted in cooperation with the U.S. Food
and Drug Administration (FDA).
