USPlabs LLC has pulled back particular OxyElite Pro dietary products because they can cause upset human livers the United States Food and Drug Administration said in a press release on their website Sunday.
"We took this step to ensure that adulterated and harmful products do not reach the American public," deputy commissioner for foods and veterinary medicine Michael Taylor said in a statement. "We will continue to work with our state, industry and regulatory partners to prevent such products from reaching the public."
The products include OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules and OxyElite Pro Super Thermo Powder.
"(The ingredient) lacks history of use or other evidence of safety," the United States Food and Drug Administration told WebMD.
According to the administration, USPlabs of Dallas was informed about the cases in a letter Nov. 6 after a connection was found between several OxyElite Pro products and liver sicknesses in Hawaii where one individual perished, while another obtained a liver transplant out of 27 people who reported taking the affected product. Blemish livers have also been reported in other states.
The FDA asked USPlabs in an Oct. 11, 2013 letter to stop production of OxyElite Pro, and VERSA-1 since they have aegeline, a substance that was not promoted in the United States prior to the establishment of the dietary and supplement health and education act of 1994 on Oct. 15, 1994 the administration reported.
Users who feel they have become ill from the product should send a report to the FDA's MedWatch hotline at 1-800-FDA-1088 or online, and inform their health care professional.
Users can also contact USPlabs at 1-800-890-3067 Monday through Friday from 9 a.m. to 5 p.m. eastern time or by e-mailing the company at info@usplabs.com.
Click here for a full list of the recalled products.
