FDA Recall D-0210-2017
Ultimate Body Tox · Rowland, NC
Class I — life-threatening Terminated 256 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0210-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Product distributed in NC and nationwide through the internet.
- Recall initiated
- 2016-11-13
- Classified by FDA Center
- 2016-12-22
- FDA published
- 2016-12-28
- Terminated
- 2017-07-27
- Recalling firm
- Ultimate Body Tox
- Firm location
- Rowland, NC