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.
D-0210-2017
Product summary
- Event
- Event 75832
- Status
- Terminated
- Classification
- Class I
- Quantity
- 25 bottles
- Official record key
drug-enforcement:D-0210-2017
Official wording
Reason: 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.
Code information: All lots and manufacturing dates.
Distribution pattern: Product distributed in NC and nationwide through the internet.
Derived failure modes
-
Unknown
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.