Bella Vi Products by Pure Edge Nutrition Recalled due to Undeclared Drug Ingredients
Consumers are informed by the FDA that certain lots of Bella Vi brand products by Pure Edge Nutrition are recalled because they were found to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein.
Background of Bella Vi Products
Bella Vi brand products, by Pure Edge Nutrition, are marketed as dietary supplements for weight loss.
FDA Alert on Bella Vi Products
FDA’s reason for the recall is that laboratory analysis revealed that these products contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein that may pose a threat to consumers. Sibutramine was removed from the US market in 2010 for safety reasons as it can increase blood pressure and/or pulse rate in some cases and may present a risk for patients with a history of stroke, arrhymias, congestive heart failure, or coronary artery disease. Phenophthalein (used as a laxative) is not approved for marketing in the US.
The affected products are: 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 Up.
FDA Recommendation on Bella Vi Products
“Pure Edge Nutrition, LLC is notifying its distributors and customers by email and is arranging for return of all recalled products. Consumers and distributors that have product which is being recalled should stop using and return products to Pure Edge Nutrition, LLC. Consumers with questions regarding this recall can contact Pure Edge Nutrition, LLC at (888) 417-3613 Monday – Friday 10:00 a.m. – 2:00 p.m. EST or email firstname.lastname@example.org.”
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