June 17, 2009
Stamina-Rx-brand supplement is recalled
The U.S. Food and Drug Administration announced the nationwide voluntary recall of Stamina-Rx-brand dietary supplement due to a safety hazard.
Officials said Hi-Tech Pharmaceuticals Inc. of Norcross, Ga., initiated the recall after the FDA found the product, described as a sexual stimulant for men, contained undeclared benzamidenafil, the same therapeutic class of active pharmaceutical ingredients found in sildenafil, tadalafil and vardenafil.
Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels,the federal agency said.
Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates and may be most susceptible to adverse effects from this product.
Stamina-Rx is sold predominantly in health food and drug stores nationwide.