November 11, 2013
FDA announced the recall of certain OxyElite Pro dietary supplements because they have been linked to various liver illnesses and are likely adulterated. OxyElite Pro and another dietary supplement called VERSA-1 contain the dietary ingredient aegeline. This ingredient has not previously been marketed in the US and safety data are lacking. FDA directed the distributor of OxyElite Pro and VERSA-1 to immediately stop marketing these products. Recalled OxyElite products include OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules, and OxyElite Pro Super Thermo Powder. For a list of recalled products and lot numbers see the FDA News Release November 10, 2013 at the link below.
In October 2013, FDA, CDC, and the Hawaii Department of Health informed the public of an ongoing investigation of a possible link between acute hepatitis and the dietary supplement labeled as OxyElite Pro. At that time, 29 cases of acute non-viral hepatitis lacking an identifiable cause had been reported in Hawaii in people who had used a dietary supplement for weight loss or muscle gain. Twenty-four of these cases involved patients who had used a product labeled as OxyElite Pro within 60 days prior to the onset of illness. On November 10, 2013, FDA announced further findings from their investigation. Twenty-seven of 46 medical records from the Hawaii Department of Health showed patients who had become ill had taken product labeled as OxyElite Pro, and 17 of these patients were taking no other dietary supplement prior to getting sick. One patient has died and 1 has received a liver transplant, with other patients awaiting liver transplant. Cases of liver illnesses linked to OxyPro Elite have also been reported in other states.
OxyElite Pro, distributed by USPlabs LLC of Dallas, Texas, is nationally available via retail stores and the internet. FDA is advising the public not to use any products labeled as OxyElite Pro or VERSA-1. Return the products for a refund to the place of purchase. Consumers are advised to consult a healthcare professional if they experience adverse events related to the use of dietary supplements. Consumers may also contact USPlabs at 800-890-3067 during business hours for additional information.
Additional information is available at the following links:
- FDA Medwatch Alert – November 10, 2013
- FDA News Release – November 10, 2013
- Firm Press Release – November 9, 2013
- FDA Medwatch Alert – October 8, 2013
- CDC Health Alert Network Advisory– October 8, 2013
- FDA Recalls, Outbreaks, and Emergencies – October 8, 2013
November 11, 2013; October 9, 2013; University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.