According to the Food and Drug Administration (FDA) has announced that OxyElite Pro products are being recalled for their link to acute liver failure and hepatitis, one such case may have resulted in death and several other cases that may have required liver transplants.
Beyond the recall, the manufacturer, USPLabs, is being required to destroy any stocks it has of the product, which is suspected to have a retail value of approximately $22 million.
“As soon as we suspected a possible link between OxyElite Pro porducts and cases of liver failure and non-viral hepatitis in Hawaii, we warned the public and immediately launched an investigation with state officials and the Centers for Disease Control and Prevention (CDC). Our mandate to protect the public was fulfilled by ensuring the swift removal of the product from the marketplace,” said Daniel Fabricant, Ph.D., director of the FDA’s Division of Dietary Supplement Programs.
Regrettably, dietary supplement manufacturers are not required to submit proof of safety and effectiveness to the FDA prior to marketing the supplement.
“It is a regrettably common occurrence that new products on the market contain hidden dangers that the public is unaware of,” commented Megan McBride an attorney with the Levin, Papantonio law firm who practices in the areas of personal injury and product liability litigation.
The FDA’s announcement is available here.