Bella Vi Brand Products by Pure Edge Nutrition: Recall - Undeclared Drug Ingredients
Including 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
ISSUE: Pure Edge Nutrition, LLC is voluntarily recalling one lot of each: 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 two lots of Bella Vi Amp’d Up, to the consumer level. FDA laboratory analyses found the products to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein. Sibutramine was removed from the US market in October 2010 for safety reasons and Phenophthalein is used as a laxative and not approved for marketing in the US. Therefore, these products are unapproved new drugs.
Products containing sibutramine and phenophthalein pose a threat to consumers because Sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking.
See the Press Release for a listing of affected products and lot numbers.
BACKGROUND: All affected products are marketed as dietary supplements for weight loss.
RECOMMENDATION: 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 email@example.com.
[03/26/2014 - Press Release - Pure Edge Nutrition]