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PURE EDGE NUTRITION, LLC ISSUES A NATIONWIDE RECALL OF DIETARY SUPPLEMENTS DUE TO DANGEROUS UNDECLARED INGREDIENTS

PURE EDGE NUTRITION, LLC ISSUES A NATIONWIDE RECALL OF DIETARY SUPPLEMENTS DUE TO DANGEROUS UNDECLARED INGREDIENTS

he FDA recently posted a press release by Pure Edge Nutrition, LLC, about the nationwide recall of certain lots of Bella Vi brand products. These products are marketed as dietary supplements for weight loss. Laboratory analyses conducted by the FDA revealed the supplements contained "undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein."

Phenolphthalein is a laxative not approved for marketing in the US. Sibutramine was taken off the US market in 2010 for safety reasons. The two unapproved substances "may... interact in life threatening ways with other medications a consumer may be taking." Sibutramine can also lead to increased blood pressure and/or pulse, as well as present additional risks in people with a history of cardiac problems.

The recall encompasses specific lots of Bella Vi Insane Bee Pollen Capsules, Bella Vi BTrim Ultimate Boost, Bella Vi BTrim Max, Bella Vi Extreme Accelerator, Bella Vi Insane Amp'd, and Bella Vi Amp'd. So far, Pure Edge Nutrition has not received reports of adverse effects related to the recalled lots.

Sources:

FDA,

http://www.fda.gov/Safety/Recalls/ucm390693.htm

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm390748.htm

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