FDA recall D-1534-2014

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.

Distribution

Worldwide via internet sales

Key facts

Status

Terminated

Initiation date

2014-04-30

Report date

2014-08-20

Termination date

2015-02-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fountain Valley, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1534-2014