The U.S. Food & Drug Administration (FDA) sent a letter to USPlabs, LLC, of Dallas, Texas, earlier this month, asserting that, OxyElite Pro dietary supplements, has been linked to liver disease.
Further, the FDA went on to state that evidence exists pointing to the possibility that the product was contaminated.
In the letter, USPlabs was notified that if the company did not initiate its own voluntary recall, the FDA would move to compel the company to stop distributing the dietary supplements and notify all third parties to stop distribution of the product.
This is only the second time since the enactment of the FDA Food Safety Modernization Act (FSMA) that the agency has exercised its authority to immediately stop the distribution of such a product.
Liver illnesses were being reported in Hawaii by those who used OxyElite Pro dietary supplement products. The Hawaii Department of Health submitted records to the FDA indicating that out of 46 sets of medical records where liver illnesses were referenced, more than half of those patients (roughly 58%) had used the OxyElite Pro supplement very recently. Among the patients reviewed there was one death, one patient who had already had a liver transplant, and several others who were waiting for liver transplants.
Later, the FDA notified USPlabs that OxyElite Pro samples had been adulterated with aegeline, a dietary ingredient without a history of consumer testing in the U.S., and with very little prior reported use. The FDA notice to USPlabs stated that failure to immediately stop distribution of OxyElite Pro supplements containing aegeline would result in further enforcement action.
If you or a loved one has used OxyElite Pro (it also goes by the name VERSA-1) and later developed liver problems, be sure to see your health care professional. Next, call 1-800-Bad-Drug and speak to one of our legal professionals right away. The call is free and there is absolutely no obligation. All information is kept strictly confidential. Call today.
