Parrish Law Firm, PLLC would like to provide you with information regarding dietary drug manufacturer, USPLabs. They are the makers of OxyELITE Pro and VERSA-1 that have caused severe and deadly side effects. These severe side effects include:
Liver failure, Liver inflammation, Hepatitis, Heart attacks, Stroke, Kidney failure, Death
USPLabs failed to sufficiently test OxyELITE Pro and VERSA-1 and failed to use adequate labeling, instructions and warnings to fully disclose the potential deadly risk and serious side effects of two separate ingredients, methylhexanamine and aegeline contained in Oxyelite PRO and VERSA-1.
Please note that UPSlabs first added methylhexanamine to these products and once this ingredient had been deemed “unsafe” the company started using aegeline (a known constituent of the bael leaf)in their product.
Methylhexanamine
Also known as: 4-Methylhexan-2-amine, 2-Amino-4-methylhexane, Dimethylamylamine, 1,3-Dimethylamylamine, 1,3-Dimethylpentylamine, 4-Methyl-2-hexanamine, DMAA. This additive has been linked to several deaths and the FDA has advised consumer not to use ANY dietary supplements labeled OxyElite Pro or VERSA-1.
On October 11, 2013, the FDA issued a warning letter to USP Labs LLC of Dallas, Texas, informing the company that “the dietary supplements OxyElite Pro and VERSA-1 are deemed to be adulterated, and that failure to immediately cease distribution of these products may result in enforcement action by the FDA.” The warning letter also states that “the products are deemed adulterated because they contain a new dietary ingredient (an ingredient not previously present in the food supply, and for which there is no history of use or other evidence of safety when used as suggested in the labeling) which lacks adequate information to provide reasonable assurance of safety”.
On October 8, 2013, the FDA posted on its website an alert to consumers of an ongoing investigation related to a growing number of reports of acute non-viral hepatitis. It also notified consumers not to use the dietary supplement product labeled OxyElite Pro while the investigation is still ongoing. The FDA is advising consumers not to use an additional product produced by USP Labs labeled VERSA-1.
Aegeline
Also known as: N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide.
In 2013, the U. S. Food and Drug Administration (FDA), along with the Centers for Disease Control Prevention (CDC), the U.S. Department of Defense (DoD) Armed Forces Health Surveillance Center, and state and local health officials, investigated an outbreak of acute non-viral hepatitis that began in Hawaii.
According to the CDC, 97 persons with acute non-viral hepatitis were identified in an outbreak. 72 of these individuals had reported exposure to an OxyElite Pro product. At least 47 of these individuals were hospitalized, at least 3 received a liver transplant, and one death was reported. The illnesses began April 10, 2013 to October 24, 2013.
FDA Warning to USPlabs, LLC
Reported on April 15, 2013
The FDA announced that it had received reports of 86 illnesses and deaths associated with supplements containing DMAA as of the previous week. The FDA said that illnesses included nervous system and psychiatric disorders, and that DMAA could be especially dangerous taken with caffeine.
October 11, 2013,
The FDA issued a warning letter to USPlabs LLC of Dallas, Texas, notifying the company that “the dietary supplements OxyElite Pro and VERSA-1 were adulterated, and that failure to immediately cease distribution of these products could result in enforcement action”.
The warning letter stated that the products were deemed to be adulterated because they contained aegeline, a new dietary ingredient (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) and was not the subject of a required notification to the FDA. The FDA only regulates supplements after they come on to the market – companies are not required to prove that their products are safe and effective before marketing them.
The Parrish Law Firm Defective Drug Attorney works with northern Virginia citizens who have suffered from defective drugs and are looking for fair compensation for their suffering. Contact us today for a free case consultation, or call us at 703-906-4229.
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A representative of the Parrish Law Firm, PLLC researched and wrote this article with Mr. Parrish’s consent. If you have any questions regarding the legal implications of what you have just read, please send us your question by clicking here so we can have our attorney review it.
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