D-0021-2017 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 19, 2016
- Initiation Date
- December 23, 2015
- Termination Date
- January 30, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 bottles
Product Description
Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA
Reason for Recall
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Distribution Pattern
Unknown
Code Information
All Lots