CLEVELAND, Ohio -- The Food and Drug Administration Sunday announced the recall of a dietary supplement called OxyElite Pro, marketed as a weight loss aid, due to multiple reports of liver damage and one death.
The action follows two FDA warnings to the Dallas-based manufacturer of the supplements, USPlabs LLC. The first, in October, stated that the supplements are considered adulterated because they contain a substance called aegeline, which “lacks a history of use or other evidence of safety.” The agency called for the company to immediately cease distribution of the products.
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“We took this step to ensure that adulterated and harmful products do not reach the American public,” said Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor in the news release. “We will continue to work with our state, industry and regulatory partners to prevent such products from reaching the public.”
Last week, FDA notified the company of a link between the supplements and cases of liver disease. The Hawaii Department of Health submitted medical records of 46 patients with liver illnesses to the FDA and more than half — 27 patients — had taken OxyElite Pro supplements. Of these patients, one died, one required a liver transplant, and others are awaiting transplants.
As of Oct. 31, a total of 56 cases have been identified nationwide. Among these cases, 22 people have been hospitalized, two people have received liver transplants, and one person has died, according to the FDA.
Products included in the recall are the OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules and OxyElite Pro Super Thermo Powder. You can see a full list of product numbers here.
The FDA continues to advise consumers not to use any products labeled OxyElite Pro, or VERSA- 1, another USPlabs product that contains aegeline.
If you think you’ve become ill from taking a supplement, contact your doctor. Health care providers can contact the FDA’s MedWatch program online or by calling 1-800-332-1088.
The action follows two FDA warnings to the Dallas-based manufacturer of the supplements, USPlabs LLC. The first, in October, stated that the supplements are considered adulterated because they contain a substance called aegeline, which “lacks a history of use or other evidence of safety.” The agency called for the company to immediately cease distribution of the products.
“We took this step to ensure that adulterated and harmful products do not reach the American public,” said Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor in the news release. “We will continue to work with our state, industry and regulatory partners to prevent such products from reaching the public.”
Last week, FDA notified the company of a link between the supplements and cases of liver disease. The Hawaii Department of Health submitted medical records of 46 patients with liver illnesses to the FDA and more than half — 27 patients — had taken OxyElite Pro supplements. Of these patients, one died, one required a liver transplant, and others are awaiting transplants.
As of Oct. 31, a total of 56 cases have been identified nationwide. Among these cases, 22 people have been hospitalized, two people have received liver transplants, and one person has died, according to the FDA.
Products included in the recall are the OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules and OxyElite Pro Super Thermo Powder. You can see a full list of product numbers here.
The FDA continues to advise consumers not to use any products labeled OxyElite Pro, or VERSA- 1, another USPlabs product that contains aegeline.
If you think you’ve become ill from taking a supplement, contact your doctor. Health care providers can contact the FDA’s MedWatch program online or by calling 1-800-332-1088.
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