FDA Recalls Dietary Supplement

The Food and Drug Administration used its new powers granted by the Food Safety Modernization Act (FSMA) for just the second time in forcing a company to recall a popular dietary supplement last week. The FDA stated in its letter to USPlabs LLC that its OxyElite Pro dietary supplements have been linked to liver problems, including liver failure. The October death of a woman in Hawaii is blamed on this defective product. Twenty-seven victims have been identified in Hawaii alone, but there are victims in several other states.

The FDA also stated that if USPLabs LLC did not recall the adulterated supplements, the FDA would order a halt in distribution, as well as notify distributors and retailers to stop selling the supplements.

The products affected by the recall include:

  • OxyElite Pro Super Thermo capsules
  • OxyElite Pro Ultra-Intense Thermo capsules
  • OxyElite Pro Super Thermo Powder

These products are used to build muscle, as well as lose weight, so their consumers vary in lifestyle. However, the results of illness are all the same due to the presence of aegeline, an ingredient the FDA says was not marketed in the US before October 1994, and one that does not have a history of use or evidence of safety. The FDA has warned consumers to not use OxyElite Pro, as well as VERSA-1 products.

If you are using this defective product, you are advised to stop immediately. If you have concerns about your liver health, see your doctor.

If you or a loved one has become seriously ill as a result of taking OxyElite Pro or VERSA-1 dietary supplements in the Bakersfield, California area, please contact the Law Offices of Mickey Fine or call (661) 333-3333 today for a free product liability case consultation.