WASHINGTON (November 11, 2013) USPlabs of Dallas is recalling its OxyElite Pro products, which are thought to have impurities and have been linked to dozens of hepatitis and liver failure cases in Hawaii and in a number of other states, too, the U.S. Food and Drug Administration says.
The dietary supplement is used for weight loss and muscle-building.
The FDA says one of the patients died, another needed a liver transplant and others are now awaiting liver transplants.
The recall followed a letter from the FDA that notified USPlabs that if the company did not initiate a voluntary recall, the FDA could by law order an immediate halt to distribution of the dietary supplements.
The action marks the second time the FDA has exercised its recall authority under the FDA Food Safety Modernization Act.
“We took this step to ensure that adulterated and harmful products do not reach the American public,” said Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor.
“We will continue to work with our state, industry and regulatory partners to prevent such products from reaching the public.”