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Linked to Liver Failure, Diet Supplement OxyElite Pro Recalled; Parker Waichman LLP Commends FDA for Invoking Rarely Used Enforcement Power in Letter to Supplements Maker
Date:11/13/2013

bubblegum and green apple). A full list of the products and their UPC codes can be found on the related page on the FDA website.

As further noted in its press release, the FDA notified USPlabs about findings indicating a link between the use of OxyElite Pro products and a number of liver illnesses reported in Hawaii. The FDA release also noted that cases of liver damage following the use of these OxyElite Pro products had also been found in a number of other states.

It added that, in a review of 46 medical records submitted to the FDA by the Hawaii Department of Health, 27 patients, or 58 percent, had taken a dietary supplement named OxyElite Pro before they became ill; 17 of the 27 patients (or 63 percent) reported that OxyElite Pro was the only dietary supplement that they were taking. One death has occurred among these patients, one patient has undergone a liver transplant, and others require transplants but are waiting for the organs to become available, the press release noted.

In a warning letter issued to USPlabs LLC on Oct. 11, 2013, the FDA informed the company that OxyElite Pro and another of its dietary supplements, called VERSA-1, had been deemed by the agency as “adulterated.” The letter pointed out that the products in question included aegeline, a new dietary ingredient that “lacks a history of use or other evidence of safety.” The letter also stated that failure to immediately cease distribution of all dietary supplements containing aegeline may result in enforcement action.

If you or someone you know has taken OxyElite Pro dietary supplement products, you may have valuable legal rights. To discuss your case with one
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