Bee Extremely Amazed LLC Recalls Infinity Capsules Tainted With Sibutramine
Bee Extremely Amazed LLC is recalling Infinity Capsules because the product was found to contain undeclared sibutramine, a withdrawn appetite suppressant.
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
Bee Extremely Amazed LLC is voluntarily recalling Infinity Capsules, 500 mg, 30-count bottles, manufactured for Floyd Nutrition. The recall covers all lots of the product, which was distributed nationwide.
The FDA determined that the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Although marketed as a dietary supplement, the product was found to be tainted with undeclared sibutramine. Sibutramine is an appetite suppressant that was previously withdrawn from the US market for safety reasons, making its presence in this product an unapproved drug.
Consumers who have purchased Infinity Capsules should stop using the product immediately. The source text does not provide specific instructions for disposal or refund procedures, but consumers should generally follow guidance from the recalling firm or the FDA regarding the safe handling of recalled medications and supplements.
The recalled product
- Product
- Infinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition
- Manufacturer
- Bee Extremely Amazed LLC
- 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)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 14 recalled by Bee Extremely Amazed LLC 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 14 products in this recall →Related recalls
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