Ultimate Body Tox recalls Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway,
Recalled December 28, 2016 · FDA recall D-0210-2017 · 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. · FDA Class I
Units
25 bottles
Sold at
Product distributed in NC and nationwide through the internet.
Description
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.
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(s)
Ultimate Body Tox
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →