D-1534-2014 Class I Terminated
FDA drug recall D-1534-2014 was initiated by Bacai Inc. Dba Ky Duyen House on April 30, 2014 and is designated Class I. 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. The recall status is terminated (terminated February 10, 2015). Affected quantity: 14,040 softgel capsules.
Recall Details
- Product Type
- Drugs
- Report Date
- August 20, 2014
- Initiation Date
- April 30, 2014
- Termination Date
- February 10, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,040 softgel capsules
Product Description
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
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.
Distribution Pattern
Worldwide via internet sales
Code Information
Lot #13165; Exp. 05/17