November 18, 2013 – Dallas, TX-based USPlabs has agreed to recall all remaining stocks of OxyElite Pro after the supplement was linked to dozens of cases of acute liver failure and hepatitis, including two liver transplants and one death. Additionally, the company has assured the U.S. Food & Drug Administration (FDA) that it will destroy warehouse stocks of the supplement, worth an estimated retail value of approximately $22 million. Consumers who have purchased OxyElite Pro have been advised to discontinue use immediately and consult a physician if they begin experiencing unexplained symptoms.
Free Confidential Lawsuit Evaluation: If you or a loved one has been injured by OxyElite Pro, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit against the manufacturer and we can help.
What’s the Problem?
On October 11, the FDA sent USPlabs a warning letter stating that OxyElite Pro and another product, VERSA-1, were determined to be adulterated because they contain a new dietary ingredient called aegeline for which the company did not provide evidence of safety.
In March, supplies of a different formulation of OxyElite Pro were destroyed after being held through an FDA administrative detention order. An ingredient included in those products, dimethylamylamine (DMAA), had been reported to cause high blood pressure, heart attacks, seizures, psychiatric disorders and sudden death.
After taking DMAA out of its supplements, USPlabs added aegeline to certain OxyElite Pro products. Non-synthetic aegeline is an alkaloid extract derived from leaves of the Asian bael tree.
Nationwide OxyElite Pro Hepatitis Outbreak
On Sept. 13, the FDA became aware of at least seven Hawaii residents who had been diagnosed with acute liver failure/non-viral hepatitis. A joint investigation by the Hawaii Department of Health (DOH) and Centers for Disease Control and Prevention (CDC) determined that the patients had all taken OxyElite Pro in the two months leading up to their injuries. Since then, the FDA has identified OxyElite Pro users outside of Hawaii with similar liver injuries. As of the end of October 2013, there were at least 56 cases of acute liver failure or acute hepatitis linked to OxyElite Pro, 43 of them in Hawaii. The investigation into the matter continues.
Do I Have an OxyElite Pro Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in OxyElite Pro lawsuits. We are handling individual litigation nationwide and currently accepting new OxyElite Pro injury and death cases in all 50 states.
Free Confidential Case Evaluation: Again, if you were injured by OxyElite Pro side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.