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Sexual stimulant supplement recall

This article was originally published in The Tan Sheet

Executive Summary

Roughly 24 mil. pills contaminated with Rx erectile dysfunction drug ingredient tadalafil, the active in Eli Lilly's Cialis, were destroyed Dec. 19 under FDA's oversight, marketers Hi-Tech Pharmaceuticals and National Urological Group report. Twenty-four lots containing 1 mil. pills each were recalled in August. FDA released a consumer warning in June alerting the public to the contamination. Manufactured by NVE Pharmaceuticals, recalled products include Stamina-Rx and Stamina-Rx for Women, Uroprin, Sigra, Spontane-ES and Vigor-Rx (1"The Tan Sheet" June 23, 2003, In Brief)...

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FDA advisory on contaminated supplements

FDA warns consumers not to purchase or consume several dietary supplements manufactured by NVE Pharmaceuticals and distributed by Norcross, Ga.-based Hi-Tech due to contamination with Rx erectile dysfunction ingredient tadalafil (Eli Lilly's Cialis). In a June 20 release, FDA notes Sigra, Stamina Rx, Stamina Rx for Women, Y-Y, Spontane ES and Uroprin, which claim to increase stamina and performance, actually pose health risks because interaction between certain Rx drugs and tadalafil "may cause a drastic lowering of blood pressure." This is of particular concern since erectile dysfunction "is often a common problem in people with diabetes, hypertension," ischemic heart disease and who smoke, FDA says. Agency notes its Office of Criminal Investigations executed concurrent federal search warrants in Georgia and New Jersey, where NVE is based, after discovering the supplements...

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