Dietary supplement OxyElite Pro has been voluntarily recalled by USPlabs after the U.S. Food and Drug Administration connected the use of the supplements to a cluster of acute liver injuries in Hawaii.
The FDA recently issued a warning letter stating that it would order USPlabs to stop distributing OxyElite Pro nationwide if the company did not voluntarily pull the dietary supplements. According to the FDA news release, “[t]his action marks the second time the FDA has invoked its recall authority under the FDA Food Safety Modernization Act (FSMA) by sending such a letter.”
Of the records submitted to the FDA for review, it was found that 58 percent of patients suffering from liver disease were taking OxyElite Pro before they became sick. Several patients required liver transplants. One patient died prior to receiving a transplant. Although the initial reports of injuries were limited to Hawaii, more states have since suggested a connection between OxyElite Pro and liver disease.
Products implicated in the recall include OxyElite Pro Super Thermo capsules, Ultra-Intense Thermo capsules, and Super Thermo powder. A complete list of products involved can be found here.
The FDA also believes that a “reasonable probability” exists that the dietary supplements are adulterated because OxyElite Pro contains aegeline. Because FDA considers aegeline to be a new dietary ingredient, USPlabs was required to notify the FDA before marketing products that use it. Although USPlabs does not agree with the FDA’s claim that aegeline is a new dietary ingredient, it has agreed to remove aegeline from its U.S. products.
If you or a loved one has suffered significant injury from a pharmaceutical or medical device, contact Lopez McHugh. We are here to discuss your options, with no obligation.