FDA orders stop use:Stamina-Rx ED recall!

FDA orders stop use:Stamina-Rx ED recall!


Erectile Dysfunction (ED) drug recalled for potentially lethal undeclared ingredient!

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.

The recalled product is packaged in 10, 30, and 40 tablet bottles. It is also sold in 2 and 6 tablet blister packs. The dietary supplement is mainly sold in health food and drug stores throughout the United States. The Gwinnett County firm, in cooperation with FDA investigators, is ordering consumers to cease consumption of the recalled items. Consumers who have incurred health problems should seek medical attention immediately. A reports should also be filed on the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm or by calling the FDA at 1-800-FDA-1088. Consumers who have been injured due to the recalled products may be entitled to compensation for their damages. Contact a Georgia product liability lawyer for further questions.

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