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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Manufacturer
- Pure Edge Nutrition
- Category
- Drug — Dietary Supplement
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 →Related recalls
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