FDA recall D-0210-2017

Ultimate Body Tox · Class I · 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.

Reason for recall

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.

Distribution

Product distributed in NC and nationwide through the internet.

Key facts

Status
Terminated
Initiation date
2016-11-13
Report date
2016-12-28
Termination date
2017-07-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rowland, NC, United States

Primary source

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