| U.S. Food and Drug Administration |
FDA Press Release, Dec 1, 2004
ACTRA-Rx Recall
FOR IMMEDIATE RELEASE -- Canoga Park, CA -- December 1, 2004 -- Body Basics
Inc., distributors of ACTRA-Rx, is warning those consumers who purchased this
product, lot number 001-3 and expiration date of December 2005, between June
2001 and June 2004, promoted for increasing sexual potency, not to use these
capsules. Body Basics had voluntarily ceased distribution of these capsules in
June 2004.
This product, marketed under the trade name ACTRA-Rx, as a dietary supplement
and sold over the counter as well as via the internet, may have been
inadvertently contaminated by the manufacturer with the unlabeled prescription
drug ingredient, sildenafil citrate, which may pose possible serious health
risks to some users. Sildenafil is known to have serious side effects, including
the potential for life-threatening side effects. The interaction between
nitrates and this drug can result in profound and life-threatening lowering of
blood pressure. Use of nitrates in any form is an absolute contraindication for
Sildenafil Citrate.
The potential for ACTRA-Rx to be taken by unknowing nitrate users is real
since health care practitioners recognize that erectile dysfunction is often a
condition in patients with diabetes, hypertension, hyperlipidemia, smokers and
patients with ischemic heart disease (potential users of nitrates). If you or
someone you know has any of these conditions and is taking ACTRA-Rx with this
particular lot number and expiration date, you are urged to contact a health
professional.
As there is no practical or economical way to determine whether the product
you purchased is so contaminated, you should immediately arrange for a return of
the product that you purchased.
You are encouraged to contact Body Basics Inc., at P.O. Box 375, Canoga Park,
CA 91303 telephone number 818-715-1000 for instructions and return policy; or,
if you have any other questions or concerns. To date no known health problems
have been reported.
This recall is being conducted in cooperation with the Food and Drug
Administration.
This advisory was prepared by the FDA Office of Public Affairs.