Bella Vi AMP'D UP Weight Loss Supplement Recalled for Undeclared Drugs
Pure Edge Nutrition is recalling Bella Vi AMP'D UP weight loss 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 AMP'D UP Advanced Weight Loss Dietary Supplement capsules. The product is sold in 60-count bottles and was distributed nationwide. The specific lots affected are # AU2013AB (expiration date 2015/05/20) and #BVAU813 (expiration date 2015/08/12).
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Testing revealed that the capsules contain undeclared sibutramine and phenolphthalein. These substances are not approved for use in dietary supplements.
Consumers who purchased these specific lots should stop using the product immediately. They should contact Pure Edge Nutrition for a refund or further instructions.
The recalled product
- Product
- Bella Vi AMP'D UP Advanced Weight Loss 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 # AU2013AB EXP: 2015/05/20 and lot #BVAU813 EXP: 2015/08/12
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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