Toms River, NJ, Pure Edge Nutrition is recalling Bella Vi dietary supplements because they contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein, making the products unapproved new drugs. Sibutramine was removed from the US market in 2010 for food safety reasons. Phenolphthalein is used as a laxative and not approved for marketing in the US. These products are marketed as dietary supplements for weight loss. There have been no reports of adverse reactions to date.
The products are Bella Vi Insane Bee Pollen Capsules in bottles of 60 capsules. The lot number is 201303 and expiration date of 03/07/14. This product was distributed to consumers and distributors nationwide from March 1, 2013 to August 31, 2013. Also recalled are Bella Vi BTrim Max, in bottles of 60 capsules. The lot number is BTX13, and expiration date 08/15/2015. That was distributed to consumers and distributors from August 31, 2013 through September 31, 2013.
Bella Vi BTrim Ultimate Boost is recalled, packaged in bottles of 30 capsules with lot number BTRM3452 and expiration date 07/03/2015. It was distributed July 1, 2013 to September 31, 2013. Bella Vi Extreme Accelerator is recalled, in bottles of 30 capsules with lot number BTRX7654 and expiration date 07/08/2015. It was distributed July 1, 2013 through September 31, 2013.
Bella Vi Insane Amp’d is recalled, in bottles of 60 capsules with lot number VINA2013, and expiration date 06/12/2015. It was distributed from June 1, 2013 through September 13, 2013. And finally, Bella Vi Amp’d Up is recalled, packed in 60 capsule bottles with lot number AU2013AB and expiration date 5/20/2015, along with lot number BVAU813, with expiration date 08/12/2015. It was distributed May 1, 2013 through September 31, 2013.
If you purchased these products, do not consume them. Return them to the place of purchase or discard them. You can report any adverse reports to the FDA MedWatch Adverse Event Reporting Program online.
