Drug 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
D-1534-2014
Product summary
- Event
- Event 68170
- Status
- Terminated
- Classification
- Class I
- Quantity
- 14,040 softgel capsules
- Official record key
drug-enforcement:D-1534-2014
Official wording
Reason: 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.
Code information: Lot #13165; Exp. 05/17
Distribution pattern: Worldwide via internet sales
Derived failure modes
-
Unknown
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.