February 23, 2011
MONROVIA, Calif.Biotab Nutraceuticals Inc. issued a voluntary recall of two lots of EXTENZE nutritional supplement tablets due to undeclared drug ingredients. Some packages bearing lot numbers 0709241 and 0509075 are counterfeit products that can pose a serious risk to health.
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 difficult to distinguish the counterfeit from the genuine product, Biotab decided to conduct this voluntary recall of the two affected lots. It is possible there may be other counterfeit products on the market that have yet to be identified.
FDA notified Biotab that 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 30 tablets divided into two 15 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Sibutramine is a controlled substance that was withdrawn from the market in October 2010 for safety reasons.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 (CAD), congestive heart failure, arrhythmias or stroke.
Biotab has been policing the marketplace for counterfeit and adulterated product purporting to be authentic Extenze, but some pirate product does get through U.S. Customs. The company noted one failsafe method for retailers to ensure products are authentic is to only purchase the product from Biotab or its limited authorized distributors. This practice should avoid the unwitting purchase of counterfeit products that are not properly labeled and that come from sources that are not mindful of customer safety.
Consumers in possession of product from the lots in question should return any unused product to its immediate supplier for a direct refund. Customers with questions can call (626) 775-6334 Monday through Friday between 9 a.m. and 4 p.m. for further instructions or information with respect to the return and refund process. Additionally, Biotab will refund the supplier for any genuine (non-counterfeit) product returned to it.
Any adverse reactions or quality problems experienced with the use of any counterfeit products may be reported to the FDAs MedWatch Adverse Event Reporting program.
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