Bella Vi Dietary Supplement Recall [US]


US FDA RecallUS/Silver Spring: Pure Edge Nutrition recalls some 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 Dietary Supplements due to undeclared Sibutramine and Phenolphthalein, both unapproved drugs. FDA: http://ht.ly/v69vB

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

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Dietary Supplements are subject to this recall:

  • Bella Vi Insane Bee Pollen Capsules is packaged in bottles of 60 capsules with lot # 201303 EXP: 14/03/07. Bella Vi Insane was distributed to consumers and distributors nationwide from March 1, 2013 – August 31, 2013.
  • Bella Vi BTrim Max is packaged in bottles of 60 capsules with lot # BTX13 EXP: 2015/08/15. Bella Vi Btrim Max was distributed to consumers and distributors nationwide from August 31, 2013 – September 31, 2013.
  • Bella Vi BTrim Ultimate Boost is packaged in bottles of 30 capsules with lot # BTRM3452 EXP: 2015/07/03. Bella Vi Btrim was distributed to consumers and distributors nationwide from July 1, 2013 – September 31, 2013.
  • Bella Vi Extreme Accelerator is packaged in bottles of 30 capsules with lot # BTRX7654 EXP: 2015/07/08. Bella Vi Extreme was distributed to consumers and distributors nationwide from July 1, 2013 – September 31, 2013.
  • Bella Vi Insane Amp’d is packaged in bottles of 60 capsules with lot # VINA2013 EXP: 2015/06/12. Bella Vi Insane Amp’d was distributed to consumers and distributors nationwide from June 1, 2013 – September 31, 2013.
  • Bella Vi Amp’d Up is packaged in bottles of 60 capsules with lot # AU2013AB EXP: 2015/05/20 and lot #BVAU813 EXP: 2015/08/12. Bella Vi Amp’d Up was distributed to consumers and distributors nationwide from May 1, 2013 – September 31, 2013.

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.

According to the FDA, its analysis revealed the products contain undeclared active pharmaceutical ingredients: sibutramine, phenolphthalein or a combination of both Sibutramine and Phenolphthalein.

Sibutramine is an appetite suppressant that was withdrawn from the US market in October 2010 due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity (producing Cancer), it is not currently approved for marketing in the United States. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established.

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Recalls Direct RIN: 3280-2014
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