USPLabs has agreed to recall and destroy over $22 million of its OxyElite Pro dietary supplements after an investigation by the Food and Drug Administration and the Centers for Disease Control and Prevention. After dozens of cases of hepatitis, one reported death, and many with illnesses so severe that they are in need of liver transplants, the FDA will oversee OxyElite Pro warehouse stocks destroyed.
OxyElite Pro, a dietary supplement, was marketed and advertised as a weight loss and muscle building aid. Earlier this year, stockpiles of OxyElite Pro and VERSA-1 were destroyed after an FDA investigation into its use of dimethylamylamine (DMAA) which has a risk of causing high blood pressure linked to heart attacks, seizures, psychiatric disorders, and death. USPLabs failed to notify the FDA when it substituted the new dietary ingredient aegeline.
The FDA requires that companies provide evidence of safety in a new dietary ingredient 75 days before it is released, something USPLabs failed to do. USPLabs did not inform the FDA when it began using DMAA and again when they supplemented aegeline in OxyElite Pro. Daniel Fabricant, the director of the FDA’s Division of Dietary Supplement Programs, stated: “Twice in a short period, this company has added new dietary ingredients to supplements without notifying the FDA and providing a reasonable expectation of safety, as required by law.”
Over 56 cases of acute liver failure or acute hepatitis and at least one death have been linked to OxyElite Pro supplements. Several patients have illnesses so severe that they require liver transplants. According to the FDA, the investigation continues.
For a full list of recalled OxyElite Pro products, click here.
If you have suffered a serious illness or have lost a loved one due to a defective product, Burnetti, PA’s product liability lawyers may be able to help you obtain the compensation you deserve. Call 1-888-BURNETTI today for more information.