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Recall Observatory FDA recall evidence

Drug 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.

D-0210-2017

November 13, 2016

Class I

Product summary

Firm
Ultimate Body Tox
Event
Event 75832
Status
Terminated
Classification
Class I
Quantity
25 bottles
Official record key
drug-enforcement:D-0210-2017

Official wording

Reason: Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.

Code information: All lots and manufacturing dates.

Distribution pattern: Product distributed in NC and nationwide through the internet.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.