FDA Recall D-1534-2014
Bacai Inc. Dba Ky Duyen House · Fountain Valley, CA
Class I — life-threatening Terminated 286 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
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.
Recall record
- Recall number
D-1534-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Worldwide via internet sales
- Recall initiated
- 2014-04-30
- Classified by FDA Center
- 2014-08-08
- FDA published
- 2014-08-20
- Terminated
- 2015-02-10
- Recalling firm
- Bacai Inc. Dba Ky Duyen House
- Firm location
- Fountain Valley, CA