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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