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U.S. Department of Health and Human Services

Safety

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Recall -- Firm Press Release

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.

Urgent --- ACTRA-Rx Recall

Contact:
Frank Estrada
818-715-1000

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.

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