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

April 30, 2014

Class I

Product summary

Firm: Bacai Inc. Dba Ky Duyen House
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
reason.no_named_rule · v1.0.0

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.