FDA Expands Counterfeit Warning on ED Supplement ExtenZe

Drug Industry Daily (c)  2009 Drug Industry Daily
May 19, 2011
Volume 10; Issue 99

(Excerpts)

“Two lots of counterfeit ExtenZe have been identified, lot numbers 1110075 and f050899, and laboratory analysis has confirmed that the counterfeit lots contain either tadalafil or a combination of tadalafil and sildenafil, according to the FDA. These products are not listed on the counterfeit products’ labeling.”

In February, ExtenZe maker Biotab voluntarily recalled two lots of the supplement after counterfeits — carrying lot numbers mimicking ExtenZe products made in 2009 — were found to contain tadalafil and sildenafil. “Because it is very difficult to distinguish the counterfeit from the genuine product, Biotab decided to conduct this voluntary recall of the two effected lots,” the company said at the time (DID , Feb. 25).

“Calling the counterfeit products “illegal and unsafe,” the FDA advises consumers to avoid ExtenZe with the offending lot numbers.”

“Where the counterfeit ExtenZe originated remains a mystery, but the FDA is looking into its source, FDA spokeswoman Lisa Kubaska told DID. “We believe these products are being manufactured outside the U.S.,” she said.”

“Though the FDA is not aware of any adverse events associated with the counterfeit ExtenZe, it “cannot be certain that the tainted ExtenZe products are isolated to the four lots discovered to date,” Kubaska said.”

This incident is an example of a growing trend of products marketed as dietary supplements or conventional foods with hidden drugs and chemicals,” Ilsa Bernstein, deputy director of CDER’s Office of Compliance, said.”

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