Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solution...
FDA Recall #D-0021-2017 — Class I — December 23, 2015
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
Recalling Firm
Bee Xtreme — Punxsutawney, PA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
13 bottles
Distribution
Unknown
Code Information
All Lots
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated