OxyElite Pro Supplement, Linked to Liver Illnesses, Recalled by ManufacturerNov 11, 2013
The U.S. Food and Drug Administration (FDA) has reported that USPlabs of Dallas is recalling OxyElite Pro products thought to have impurities. The dietary supplement is used for weight loss and muscle-building.
After linking OxyElite products to dozens of hepatitis and liver failure cases in Hawaii, investigators linked the pills to cases in a number of other states, too, according to The Associated Press (AP). The FDA reports that one patient died, another received a liver transplant, and others are now awaiting liver transplants.
USPlabs initiated the voluntary recall after receiving a letter from the FDA warning the company that the products have been linked to liver illnesses and that there is a reasonable probability that the products are adulterated. The letter also notified USPlabs that if the company did not initiate a voluntary recall, the FDA could by law order an immediate halt to the distribution of the supplements. The recalled products are OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules, and OxyElite Pro Super Thermo Powder. A full list of the products and their UPC codes can be found on the FDA website.
Symptoms of hepatitis include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay colored bowel movements, joint pain, yellow eyes, and jaundice.
A review of 46 medical records submitted to the FDA by the Hawaii Department of Health found that 27 patients, or 58 percent, had taken a dietary supplement labeled OxyElite Pro before becoming ill. The investigation also has revealed that liver injury cases in other states may be linked to OxyElite Pro products.
OxyElite Pro and another dietary supplement, VERSA-1, were deemed to be adulterated. The products contained aegeline, a dietary ingredient that lacks a history of use or other evidence of safety. Failure to immediately cease distribution of all dietary supplements containing aegeline may result in FDA enforcement action.
The FDA advises consumers not to use any supplements labeled OxyElite Pro or VERSA-1 and to consult a doctor if they believe they have been harmed by a dietary supplement.