OxyElite Pro™ Dietary Supplements Recalled by Manufacturer After Reports of Liver Illnesses
The FDA reports that the manufacturer of OxyElite Pro™, USPLabs, issued a recall of the dietary supplement on November 9, 2013.
The company decided to recall OxyElite Pro™ products “after receiving a letter from the U.S. Food and Drug Administration (FDA) stating that the products have been linked to liver illnesses and that there is reasonable probability that the products are adulterated.” The November 6, 2013 letter from the FDA notified USPlabs that if the company did not initiate a voluntary recall, the FDA could by law order the company to cease distributing the product. Such an action marks only the second time that the FDA has utilized its recall authority under the FDA Food Safety Modernization Act (FSMA) by sending such a letter to a manufacturer.
The letter was based on the fact that the FDA has received numerous reports of cases of acute liver failure and hepatitis, including one death and several patients requiring liver transplants. On September 13, 2013, the FDA learned that seven residents of Hawaii using OxyElite Pro™ products suffered acute liver failure/non-viral hepatitis. As a result, the FDA issued a Safety Alert on October 8, 2013 warning the public to “stop using any dietary supplement product labeled as OxyElite Pro™ while the investigation continues.” On October 11, 2013, the FDA informed the company that the dietary supplements were deemed adulterated because they contain a new dietary ingredient (aegeline) which lacks adequate information to assure safety, and that failure to cease distribution may result in enforcement action by the FDA. At the end of October 2013, there were 56 cases of acute liver failure/acute hepatitis linked to OxyElite Pro™, 43 of them in Hawaii. The FDA reports that its investigation is still continuing.
OxyElite Pro™ was advertised as a dietary supplement to promote weight loss and help build muscle. The products involved in the recall include the following (click here for a full listing of the products within each product line):
- OxyElite Pro™ Super Thermo Capsules
- OxyElite Pro™ Ultra-Intense Thermo Capsules
- OxyElite Pro™ Super Thermo Powder
In light of the product recall, USPLabs has informed the FDA that it will destroy warehouse stocks of the supplement, with a retail value of approximately $22 million. The FDA has agreed to oversee the destruction of the remaining products.
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