Drug product
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
D-0021-2017
Product summary
- Firm
- Bee Xtreme
- Event
- Event 73167
- Status
- Terminated
- Classification
- Class I
- Quantity
- 13 bottles
- Official record key
drug-enforcement:D-0021-2017
Official wording
Reason: Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Code information: All Lots
Distribution pattern: Unknown
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein