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Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted October 9, 2013
FDA Warns Consumers Not to Use OxyElite Pro As It Investigates Link With Hepatitis
According to the Hawaii Department of Health (DOH), there have been 29 cases of acute non-viral hepatitis in which the cause could not be identified. Of these, 24 are associated with the use of OxyElite Pro; eleven people have been hospitalized with acute hepatitis, two people have received liver transplants, and one person has died. The Centers for Disease Control and Prevention (CDC), the Hawaii DOH and the FDA are currently investigating the connection between OxyElite Pro and these cases.
As part of its investigation, the FDA is analyzing samples of OxyElite Pro collected from some of the people who’ve become ill with hepatitis, and inspecting USPLabs facilities where the supplement is made. The agency is also investigating whether counterfeit versions of the supplement have been associated with the cases of hepatitis.
OxyElite Pro is sold nationwide online and in retail stores. The supplement was pulled from shelves and inventory was destroyed in July 2013 because it contained the illegal ingredient DMAA, which is associated with an increased risk of cardiovascular events like stroke and heart attack.
According to a statement by USPLabs, "The original version [of OxyElite Pro] with DMAA has not been manufactured or distributed since early 2013." The company also stated it knows of no "credible evidence linking OxyElite Pro to liver issues."
Symptoms of hepatitis can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint pain, yellow eyes, and jaundice.
Consumers who have purchased this supplement should discontinue use immediately and contact their healthcare provider if they have experienced any adverse side effects. Consumers and healthcare providers are also encouraged to report any adverse reactions to the FDA's MedWatch Adverse Event Reporting Program.
See Related Warnings:
USPLabs Settles Class Action Lawsuit Over Controversial DMAA Ingredient
USPLabs Destroys $8 Million Worth of Supplements Containing DMAA
FDA Warns Consumers About The Dangers Of DMAA
FDA Warns USPLabs For Adulteration and Drug Claims
To read the FDA’s warning, use the link below.
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