Biotab Nutraceuticals, Inc. (“Biotab”) is recalling of two lots of EXTENZE nutritional supplement tablets.
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 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, drugs used to treat erectile dysfunction (ED), 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Sibutramine is a controlled substance that was withdrawn from the market in October 2010 for safety reasons. It 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.
Fake product
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 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 (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.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, using postage-paid, pre-addressed Form FDA 3500 available here and sending it to the address on the pre-addressed form or by fax at 1-800-FDA-0178
