November 2016 FDA Recall Drug by Ultimate Body Tox
D-0210-2017 - Marketed Without An Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Ultimate Body Tox on November 13, 2016 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0210-2017

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.
Initiated
11-13-2016
Reported
12-28-2016
Quantity
25 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75832
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ultimate Body Tox
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product distributed in NC and nationwide through the internet.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-27-2017
Product Description About Product Description
Full technical description of the product.
Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.

Batch or Lot Expiration Information

Lot# All lots and manufacturing dates.