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Hi-Tech sex supplement on recall

This article was originally published in The Tan Sheet

Executive Summary

The Norcross, Ga.-based firm voluntarily recalls all lots of its Stamina-Rx Maximum Sexual Stimulant supplement product, after FDA found samples containing the active pharmaceutical ingredient benzamidenafil. The API is in the same class as substances found in FDA-approved Rx erectile dysfunction treatments Viagra (sildenafil) and Cialis (tadalafil), Hi-Tech Pharmaceuticals said June 15. The agency determined Stamina-Rx is an unapproved new drug, not generally recognized as safe for uses suggested in Web-based labeling, and poses danger to consumers with high blood pressure or cholesterol. Since September 2003, Hi-Tech CEO Jared Wheat has been under a consent decree with FDA barring him from selling Stamina-Rx and other impotency remedies (1"The Tan Sheet" Oct. 13, 2003). Wheat was sentenced to 50 months in federal prison in February, and Hi-Tech was placed on five years' probation for the production and sale of counterfeit drugs (2"The Tan Sheet" Feb. 9, 2009, In Brief)

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