Pritzker Hageman attorneys are investigating the hepatitis outbreak in Hawaii linked to OxyElite Pro, an over-the-counter dietary supplement. The distributor, USPlabs LLC, is claiming the outbreak was caused by counterfeit versions of OxyElite Pro are being marketed in the United States. The Food and Drug Administration (FDA) is investigating these claims.
To date there are 29 reports of acute hepatitis in Hawaii, with at least 24 of them linked to taking OxyElite Pro, according to the FDA. Eleven of the 29 cases have been hospitalized with acute hepatitis, two cases have received liver transplants and one person has died. The Hawaii Department of Health (DOH) and the Centers for Disease Control and Prevention (CDC) are working with the FDA to further investigate this outbreak in Hawaii. In addition, the CDC is looking at other cases of liver injury nationwide that may be related.
They are asking anyone with symptoms of acute hepatitis who has used OxyElite Pro to call them and have any leftover tablets tested. They are urging users of OxyElite Pro not to throw out bottles until they are certain no one has been sickened. The bottles may be needed as evidence to prove that the product that caused the outbreak was not counterfeit and was distributed by USPlabs LLC.
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. Hepatitis causes liver failure and other liver damage, so it is extremely important that anyone with these symptoms seek medical attention immediately.
OxyElite Pro NOT Recalled
OxyElite Pro is distributed by USPlabs LLC of Dallas, Texas, and is sold nation-wide over the internet and in retail stores that sell dietary supplements. Eleven of the 29 cases have been hospitalized with acute hepatitis, two cases have received liver transplants and one person has died. CDC is also looking at other cases of liver injury nationwide that may be related.
Today, the FDA issued a Health Advisory, not a recall, of OxyElite Pro products.
The FDA is working with Hawaii DOH to review the medical records and histories of patients identified by DOH. The FDA is also analyzing the composition of OxyElite samples that have been collected from some of these patients, both to test for hepatitis and to determine if they are counterfeit as USPlabs claims. Additionally, the FDA is inspecting the facilities involved in manufacturing the product and reviewing production and product distribution records.
The FDA Health advisory advises consumers to stop using any dietary supplement product labeled as OxyElite Pro while the investigation continues.
We are calling on USPlabs LLC to go further and recall these products during the investigation. If these products are the cause of severe injuries and wrongful death, they need to be taken off of the market as soon as possible.
You can contact our attorneys for a free consultation here regarding a personal injury or wrongful death lawsuit against USPlabs and possibly others.