56 cases of acute liver failure or acute hepatitis.
On Sept. 13, 2013, FDA learned of a cluster of seven Hawaii residents with acute liver failure/non-viral hepatitis.
A joint investigation by the Hawaii Department of Health and CDC revealed that the patients all had consumed OxyElite Pro products. FDA meanwhile identified patients outside of Hawaii with similar liver dysfunction after using OxyElite Pro.
The FDA urged the public to avoid using products labeled as OxyElite Pro or VERSA-1 while the agency investigated further.
On Oct. 11, 2013, FDA warned the company that certain OxyElite Pro and VERSA-1 products were deemed adulterated and that failure to immediately cease distribution of both products could lead to enforcement actions. The FDA also outlined its findings of harm linked to OxyElite Pro.
As of the end of October 2013, there were 56 cases of acute liver failure or acute hepatitis linked to OxyPro Elite, 43 of them in Hawaii. The investigation continues. And, a Lawsuit was Filed by our local counsel in Hawaii.