Bella Vi BTrim MAX Recalled for Undeclared Sibutramine and Phenolphthalein
Pure Edge Nutrition is recalling Bella Vi BTrim MAX dietary supplements because they contain undeclared sibutramine and phenolphthalein and were marketed without FDA approval.
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. The presence of undeclared pharmaceutical ingredients in a dietary supplement poses a significant risk to consumer health.
Plain-English summary
Pure Edge Nutrition, LLC is recalling Bella Vi BTrim MAX Dietary Supplement capsules, 60 count bottles. The product was distributed nationwide. The specific lot number is BTX13 with an expiration date of 08/15/2015.
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 are active pharmaceutical ingredients that were not listed on the product label.
Consumers who have 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 MAX Dietary Supplement capsules, 60 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 # BTX13 EXP: 2015/08/15
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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