Ultimate Body Tox PRO capsules recalled for undeclared sibutramine
FDA is recalling Ultimate Body Tox PRO capsules because they contain undeclared sibutramine, a controlled substance removed from the market for safety reasons.
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
The U.S. Food and Drug Administration is recalling Ultimate Body Tox PRO capsules, a proprietary blend manufactured for JSN Health. The product is being recalled because it contains undeclared sibutramine. Sibutramine is a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons.
The presence of sibutramine renders the product an unapproved drug for which safety and efficacy have not been established. The recall covers 25 bottles of the 45-count, 350 mg capsules. All lots and manufacturing dates are affected.
The product was distributed in North Carolina and nationwide through the internet. Consumers who have this product should stop using it and contact the recalling firm or their healthcare provider for instructions on how to dispose of the product safely.
The recalled product
- Product
- Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.
- Manufacturer
- Ultimate Body Tox
- Category
- Drug — Dietary Supplement
- Affected units
- 25
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 and manufacturing dates.
Distribution
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