Biotab Neutraceutical Extenze tablets are nutritional tablets used for supplementing the diet. Recently, the U.S. Food and Drug Administration (FDA) discovered that another company, unconnected with Biotab, has packed a drug product with the same packaging as Extenze and used the same lot numbers used by Biotab to make it seem as if it is a Biotab product. It is virtually indistinguishable from the genuine product but the counterfeit one is not a nutritional supplement and contains three drugs called tadalafil, sildenafil and sibutramine. Tadalafil and sildenafil are drugs used to treat erectile dysfunction (ED).
Sibutramine is a controlled drug that was withdrawn for safety reasons in 2010 due to the fact that it substantially increases blood pressure and pulse rate in some people and may be a significant risk to people with coronary heart disease, congestive heart failure, arrhythmias or a history of stroke.
The counterfeit product may also interact with nitrates found in prescription drugs and lower the blood pressure to dangerous levels. Nitrates are found in drugs for diabetes, high blood pressure, high cholesterol and heart disease.
Due to the difficulty in distinguishing the fake product from the real one, Biotab is recalling two entire lots: lot number 0509075 and lot number 0709241.
0509075 is a box of 30 tablets divided into two 15 tablet blister packs, and 0709241 is a carded four pack. It is possible that there may be other counterfeit products using Biotab’s lot numbers, but the FDA has not yet found any. To avoid purchasing fake products, only buy directly from Biotab or one of its authorized distributors.
Customers who have any product with the lot numbers mentioned should not take the tablets and return them to the supplier for a refund. Customers with questions can call 626-775-6334 for help with the return and refund of their product.
Anyone who has experienced side-effects can report it to the FDA online, at:
http://www.fda.gov/MedWatch/report.htm