Biotab learned about the problem after being notified by the Food and Drug Administration (FDA) that two lots of counterfeit product purporting to be EXTENZE contain undeclared drug ingredients. More specifically, lot 0709241 contains tadalafil and sildenafil, and lot 0509075 contains tadalafil and sibutramine. The counterfeit products are sold at retail nationwide in the form of carded four-packs (lot 0709241) and in the form of a box of thirty tablets divided into two fifteen tablet blister packs (lot 0509075).
Tadalafil and sildenafil are drugs used to treat erectile dysfunction (ED). These drugs may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek Extenze to enhance sexual performance.
Sibutramine is a controlled substance that was withdrawn from the market in October 2010 for safety reasons. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
The counterfeit Extenze product is not manufactured, distributed or packaged by Biotab, but is falsely marked with the same lot numbers used by Biotab for its genuine product. Because it is very difficult to distinguish the counterfeit from the genuine product, Biotab decided to conduct this voluntary recall of the two affected lots. It is possible that there may be other counterfeit products on the market that have yet to be identified.