D-0210-2017 Class I Terminated
FDA drug recall D-0210-2017 was initiated by Ultimate Body Tox on November 13, 2016 and is designated Class I. 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 Oct… The recall status is terminated (terminated July 27, 2017). Affected quantity: 25 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 28, 2016
- Initiation Date
- November 13, 2016
- Termination Date
- July 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 bottles
Product Description
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 Pattern
Product distributed in NC and nationwide through the internet.
Code Information
All lots and manufacturing dates.