Ultimate Body Tox PRO capsules recalled over undeclared sibutramine

Recall date

November 13, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ultimate Body Tox recalls Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway,…

Recall number

D-0210-2017

FDA classification

Class I

Brand / firm

Ultimate Body Tox

Sold / distributed

Product distributed in NC and nationwide through the internet.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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