Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solution...

FDA Recall #D-0021-2017 — Class I — December 23, 2015

Recall #D-0021-2017 Date: December 23, 2015 Classification: Class I Status: Terminated

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