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OxyElite Pro Possible Link to Serious Liver Damage; Pulled from Stores



Washington, DC: On November 9, 2013, USPlabs LLC, of Dallas, TX, recalled certain OxyElite Pro dietary supplement products as a result of a U.S. Food and Drug Administration (FDA) investigation concerning a potential link to liver illnesses and a reasonable probability that the products are adulterated.

In a letter from the FDA, USPlabs was notified that if the company did not initiate a voluntary recall, the FDA could by law order the company to immediately stop distributing the dietary supplements and immediately notify other parties to stop distributing the dietary supplements.

The products involved in the recall include:

OxyElite Pro Super Thermo capsules
  • 2 count capsules UPC #094922417275
  • 10 count capsules UPC #094922417251
  • 10 count capsules UPC #094922417268
  • 21 count capsules UPC #094922426604
  • 90 count capsules UPC #094922395573
  • 90 count capsules "Pink label" UPC #094922447906
  • 180 count capsules UPC #094922447852

  • OxyElite Pro Ultra-Intense Thermo capsules
  • 3 count capsules UPC #094922447883
  • 3 count capsules UPC #094922447876
  • 90 count capsules UPC #094922395627
  • 180 count capsules UPC #094922447869

  • OxyElite Pro Super Thermo Powder:
  • Fruit Punch 0.15 oz UPC #094922417237
  • Fruit Punch 0.15 oz UPC #094922447517
  • Fruit Punch 4.6 oz UPC #094922426369
  • Fruit Punch 5 oz. UPC #094922447487
  • Blue Raspberry 4.6 oz UPC #094922426376
  • Grape Bubblegum 4.6 oz UPC #094922447500
  • Green Apple 4.6 oz. UPC #094922426499

  • In a letter dated Nov. 6, 2013, the FDA notified USPlabs about findings indicating a link between the use of the above OxyElite Pro products and a number of liver illnesses reported in Hawaii. The FDA also noted that cases of liver damage after use of these OxyElite Pro products had been reported in a number of other states.

    In a review of 46 medical records submitted to the FDA by the Hawaii Department of Health, the records indicated that 27 patients, or 58 percent, had taken a dietary supplement labeled as OxyElite Pro prior to becoming ill. Seventeen of the 27 patients (or 63 percent) reported that OxyElite Pro was the only dietary supplement they were taking. One death has occurred among these patients, another patient has required a liver transplant, and others await liver transplants.

    Symptoms of all types of hepatitis are similar and can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay colored bowel movements, joint pain, yellow eyes, and jaundice.

    The FDA advises consumers to discontinue using any dietary supplement products labeled as Oxy Elite Pro and VERSA-1 while the investigation continues. OxyElite Pro and VERSA-1 are distributed by USPlabs LLC of Dallas, Texas, and are sold nationwide through retail stores, mail orders and direct delivery.

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