Class I
Terminated
Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.
- Company
- Ultimate Body Tox
- Recall Initiated
- November 13, 2016
- Posted
- December 28, 2016
- Recall Number
- D-0210-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 25 bottles
- Firm Location
- Rowland, NC, United States
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.
Lot / Code Info
All lots and manufacturing dates.
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