FDA Recalls Ultimate Formula Capsules Tainted With Undeclared Sibutramine
Bee Extremely Amazed LLC is recalling Ultimate Formula Capsules because they contain undeclared sibutramine, a withdrawn drug.
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 recalling Ultimate Formula Capsules, 250mg, 48-count bottles, manufactured for Zi Xiu Tang Success, LLC. The product was marketed as a dietary supplement but was found to be tainted with undeclared sibutramine.
Sibutramine is an appetite suppressant that was withdrawn from the US market for safety reasons. Its presence makes the product an unapproved drug that was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The recall covers all lots of the product, which was distributed nationwide.
Consumers who have purchased this product should stop using it and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- Ultimate Formula Capsules, 250mg, 48-count bottles, Manufactured for: Zi Xiu Tang Success, LLC Trexlertown, PA 18087, USA www.zixiutangsuccess.com
- 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.
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