The Recall Desk
CriticalFDA (Drugs)·D-1368-2014·Announced 2014-06-18

Bella Vi eXtreme ACCELERATOR Recalled for Undeclared Sibutramine and Phenolphthalein

Pure Edge Nutrition is recalling Bella Vi eXtreme ACCELERATOR capsules because they contain undeclared sibutramine and phenolphthalein.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Pure Edge Nutrition, LLC is recalling Bella Vi eXtreme ACCELERATOR Dietary Supplement Capsules, 30 count bottles. The product was distributed nationwide.

The recall was initiated because the product was marketed without an Approved NDA/ANDA and was found to contain undeclared sibutramine and phenolphthalein. These undeclared ingredients pose a risk to consumers who may be sensitive to them or who are taking other medications.

Consumers who have purchased this product should stop using it and contact Pure Edge Nutrition for further instructions.

The recalled product

Product
Bella Vi eXtreme ACCELERATOR Dietary Supplement Capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • lot # BTRX7654 EXP: 2015/07/08

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Pure Edge Nutrition under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →