November 10, 2013 — OxyElite Pro has finally been recalled, months after health officials warned that it may be causing an epidemic of liver injuries. According to the OxyElite Pro recall from the U.S. Food and Drug Administration (FDA), there is a “reasonable probability” that OxyElite Pro is adulterated and illegal to sell.
Health officials first linked OxyElite Pro to liver injuries in September 2013. They quickly identified dozens of cases dating back to at least May. USPLabs did not immediately issue a recall, so Hawaiian health officials embargoed shipments and ordered stores to take it off shelves.
The FDA sent USPLabs a Warning Letter in October after finding a probable “causal connection” between OxyElite Pro and liver damage. They also found that OxyElite Pro and VERSA-1 contained aegeline, an unapproved and illegal ingredient in dietary supplements.
USPLabs still did not voluntarily issue a recall. Finally, on November 6, the FDA threatened to use its authority to force an OxyElite Pro recall. This is the second time the FDA has asserted such authority granted under the Food Safety Modernization Act (FMA) of 2011.
In the official recall announcement, the FDA also outlined evidence linking OxyElite Pro to liver damage:
“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.”
Products Included In OxyElite Pro Recall
- OxyElite Pro Super Thermo capsules
- two 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
- three count capsules UPC #094922447883
- three 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
Do I have an OxyElite Pro Lawsuit?
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