August 2013 FDA Recall Drug by Ctv Best Group
D-1154-2014 - Marketed without an Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Ctv Best Group on August 1, 2013 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-1154-2014

Reason for Recall
Marketed without an Approved NDA/ANDA: Product contains an undeclared drug, sibutramine, making it an unapproved new drug.
Initiated
08-01-2013
Reported
03-19-2014
Quantity
593 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65900
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.
CTV Best Group
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Australia, Canada.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-29-2015
Product Description About Product Description
Full technical description of the product.
BEST Slim, Dietary Supplement, 100% Natural Weight Loss Pill, 40 Pills per bottle, Distributed by CTV Best Group Inc., P.O. Box 956452, Duluth, GA 30095.

Batch or Lot Expiration Information

Lot# All lots (lot 109400, Exp 12/31/2016)