Identification of Counterfeit Products Prompts Manufacturer to Recall Two Lots Extenze Supplements

March 4, 2011 9:43 am Topics: Counterfeit drugs

Biotab Nutraceuticals, Inc has voluntarily recalled two lots of Extenze^TM nutritional supplement tablets, as Food and Drug Administration (FDA) has identified counterfeit versions of the product that bear the same lot numbers and may pose serious health risks. Specifically, some packages with the lot number 0709241 are counterfeit and contain tadalafil and sildenafil, and some packages bearing the lot number 0509075 are counterfeit and contain 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).

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. A Biotab Nutraceuticals press release posted on the FDA Web site provides more information about the potential health risks associated with tadalafil and sildenafil, as well as information about sibutramine, a controlled substance that was withdrawn from the market in October 2010 for safety reasons.

Consumers in possession of product from the lots in question can call 626/775-6334 for instructions or information about the return and refund process. Any adverse reactions or quality problems experienced with the use of any counterfeit products may be reported to FDA’s MedWatch Adverse Event Reporting program.