Stamina-Rx recall from the FDA â?? Food Supplement for ED

When I looked at the website, the company also has a problem with a fake product using the same name and bottle.  I guess it’s back to Cialis and Viagra to be on the safety approved list for ED until the product is deemed safe.   The food supplement was still for sale on the web, but perhaps these are not the lots being recalled.  Contact the FDA with any questions seems to be the best approach of taking the product as there’s an undeclared ingredient that could pose issues for some.  BD 

Atlanta, GA(JusticeNewsFlash.com)–Federal FDA regulators and Hi-Tech Pharmaceuticals, Inc., issued a recall on June 15, 2009, for all lots  of Stamina-Rx. Stamina-Rx is a men’s dietary supplement to treat erectile dysfunction (ED). The Food and Drug Administration (FDA) www.fda.gov is an agency under the United States Department of Health and Human Services (HHS) http://www.hhs.gov. The FDA is responsible for maintaining the safety of cosmetics, veterinary products, medical devices, blood products, drugs, vaccines, dietary supplements, and foods. 

Hi-Tech, a pharmaceutical company based out of Norcross, Georgia, was made aware, by the FDA, that an undeclared substance,benzamidenafil, was found in their Stamina-Rx product. Benzamidenafil is a Phosphodiesterase Type 5 (PDE5) inhibitor. PDE5 inhibitors are used in the treatment of ED. However, benzamidenafil has not been approved for U.S. consumer use by the FDA. Consumers taking nitrates should not take PDE5 inhibitors (benzamidenafil); doing so may cause adverse reactions, such as lowering blood pressure to a risky level. People with heart disease, high cholesterol, high blood pressure, or diabetes often take prescription drugs containing nitrates.