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OxyElite Pro Are Being Recalled By FDA. OxyElite Pro is a brand of weight-loss/muscle-building supplements, some of which were recalled in November 2013 by the U.S. Food and Drug Administration (FDA), which stated that the products had been linked to liver illnesses – and also noted that there was a “reasonable probability” that the […]
OxyElite Pro Are Being Recalled By FDA. OxyElite Pro is a brand of weight-loss/muscle-building supplements, some of which were recalled in November 2013 by the U.S. Food and Drug Administration (FDA), which stated that the products had been linked to liver illnesses – and also noted that there was a “reasonable probability” that the products were adulterated as well due to the inclusion of a new ingredient, the safety of which has been called into question. This is because nothing is known about the product with regards to side effects. In addition, OxyElite Pro manufacturer USPlabs’ failed to provide required historical information about this ingredient to the FDA despite the agency’s request for it.
Recalled products included OxyElite Pro Super Thermo capsules, OxyElite Pro Ultra-Intense Thermo capsules and OxyElite Pro Super Thermo Powder (available in the flavors fruit punch, blue raspberry, grape bubblegum and green apple).
According to the FDA, it notified USPlabs about findings indicating a link between the use of OxyElite Pro products and a number of liver illnesses reported in Hawaii. The FDA also noted that cases of liver damage following the use of these OxyElite Pro products had also been found in a number of other states. It added that, in a review of 46 medical records submitted to the FDA by the Hawaii Department of Health, 27 patients, or 58 percent, had taken a dietary supplement named OxyElite Pro before they became ill; 17 of the 27 patients (or 63 percent) reported that OxyElite Pro was the only dietary supplement that they were taking. One death has occurred among these patients, one patient has undergone a liver transplant, and others require transplants but are waiting for the organs to become available.
In February 2014, a consumer filed a lawsuit against USPlabs, LLC and Vitamin Shoppe Industries, Inc. in the U.S. District Court for the Southern District of Florida. The plaintiff, a male resident of Monroe County, Florida, bought Oxyelite Pro in July and November of 2013 from the Vitamin Shoppe. He suffered from acute, non-viral hepatitis and other liver damage, allegedly because of Oxyelite Pro.
The OxyElite Pro consumer alleged that USPLabs LLC and Vitamin Shoppe Industries, Inc. were negligent in designing and manufacturing a product with ingredients that could have such harmful effects on consumers. Furthermore, it is alleged that they failed to warn tabout the dangers of Oxyelite Pro and misrepresented it as safe.
Because USPlabs and Vitamin Shoppe failed to act responsibly, the suit alleges, the Plaintiff endured bodily injury, pain and suffering, disability, mental anguish, loss of the ability to enjoy life, medical treatment and expenses and loss of income. The defendants’ behavior is described as being “grossly negligent,” meaning that they were so reckless and careless to such a degree that it led to a complete disregard or indifference for the consumer’s life.
The following products are included in the recall and were distributed nationwide through retail stores, mail orders and direct delivery.
In an earlier warning letter issued to USPlabs LLC, the FDA informed the company that OxyElite Pro and another of its dietary supplements, called VERSA-1, had been deemed by the agency as “adulterated.” The letter pointed out that the products in question included aegeline, a new dietary ingredient that “lacks a history of use or other evidence of safety.” The letter also stated that failure to immediately cease distribution of all dietary supplements containing aegeline may result in enforcement action.
According to the FDA, the two supplements are considered adulterated because they contain aegeline, A manufacturer must show evidence that a new ingredient is safe when used as suggested in the product labeling. The FDA says that USP Labs failed to provide the evidence required by law that aegeline (N--3-phenyl-2-propenamide) is safe for use in dietary supplements.
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