The Recall Desk
CriticalFDA (Drugs)·D-1367-2014·Announced 2014-06-18

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.

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 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

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 →