April 2014 FDA Recall Drug by Bacai Inc. Dba Ky Duyen House
D-1534-2014 - Marketed Without an Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Bacai Inc. Dba Ky Duyen House on April 30, 2014 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in Worldwide via internet sales and the recall is currently terminated.

Recall Number: D-1534-2014

Reason for Recall
Marketed Without an Approved NDA/ANDA: Bacai, Inc. DBA Ky Duyen House is voluntarily recalling Lite Fit USA, lot 13165, due to undeclared sibutramine, making it an unapproved new drug.
Initiated
04-30-2014
Reported
08-20-2014
Quantity
14,040 softgel capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68170
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.
Bacai Inc. Dba Ky Duyen House
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.
Worldwide via internet sales
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-10-2015
Product Description About Product Description
Full technical description of the product.
Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boosts Metabolism, Limits Fat Absorption, Increases Energy, Prevents lipid formation by limiting fat absorption 30 pills /Bottle, Distributed by: Bacai, INC. www.litefitusa.com

Batch or Lot Expiration Information

Lot# 13165; Exp. 05/17