Bella Vi BTrim Ultimate Boost Recalled for Undeclared Dangerous Ingredients
Pure Edge Nutrition is recalling Bella Vi BTrim Ultimate Boost 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 indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.
Plain-English summary
Pure Edge Nutrition, LLC is recalling Bella Vi BTrim ULTIMATE BOOST Dietary Supplement capsules, 30 count bottles. The product was distributed nationwide and is identified by lot number BTRM3452 with an expiration date of July 3, 2015.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product was found to contain undeclared sibutramine and phenolphthalein. These substances are not approved for use in dietary supplements and can pose significant health risks.
Consumers who purchased this product should stop using it immediately. They should contact Pure Edge Nutrition for further instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Bella Vi BTrim ULTIMATE BOOST 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 # BTRM3452 EXP: 2015/07/03
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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