Biotab Nutraceuticals, Inc. is conducting a voluntary recall of two lots of Extenze Nutritional Supplement Tablets, the U.S. Food and Drug Administration (FDA) just announced.
Some packages bearing lot numbers 0709241 and 0509075 are counterfeit products containing undeclared drug ingredients that can pose a serious risk to health. Biotab learned about the problem after being notified by the FDA that two lots of counterfeit product purporting to be Extenze contain undeclared drug ingredients. The Recalled Counterfeit Supplement Products are sold at retail outlets nationwide:
- Lot 0709241 contains tadalafil and sildenafil and sold in carded four-packs.
- Lot 0509075 contains tadalafil and sibutramine and sold in a box of 30 tablets divided into two 15-tablet blister packs.
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Sibutramine is a controlled substance that was withdrawn from the market in October 2010 for safety reasons.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.
Consumers in possession of the Recalled Product from the lots in question only should return any unused product to its immediate supplier for a direct refund. Customers with questions can call 1.626.775.6334, Monday through Friday, between 9:00 a.m. and 4:00 p.m. for further instructions or information regarding the return and refund process. 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 FDA’s MedWatch Adverse Event
Reporting program either online, by regular mail, or by fax. By regular mail, use postage-paid, pre-addressed Form FDA 3500 available at there website and mail to the address on the pre-addressed form or fax to 1.800.FDA.0178.
Biotab explained that despite its efforts to stop counterfeit and adulterated product purporting to be authentic Extenze from entering the country, some pirate product does get through U.S. Customs. Biotab notes that the best way in which to ensure authentic Biotab is purchased is to only purchase the product from Biotab or its limited authorized distributors.