FDA-Drug2016-12-28Class I

Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.

Ultimate Body Tox
Hazard

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.

Sold states
Product distributed in NC and nationwide through the internet.
Affected count
25 bottles
Manufactured in
PO Box 637, N/A, Rowland, NC, United States
Products
Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0210-2017

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