Why it was recalled
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.
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
Lot numbers, UPCs & expiration codes
Lot #13165; Exp. 05/17
Where it was sold
Worldwide via internet sales
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1534-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 30, 2014
- FDA report date
- Aug 20, 2014
- Quantity
- 14,040 softgel capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bacai Inc. Dba Ky Duyen House
Original FDA data
Every field from FDA enforcement report D-1534-2014, exactly as published.
Show all FDA fields
- City
- Fountain Valley
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 68170
- Address
- 16165 Brookhurst St
- Code information
- Lot #13165; Exp. 05/17
- Postal code
- 92708-1550
- Report date
- Aug 20, 2014
- Product type
- Drugs
- Recall number
- D-1534-2014
- Classification
- Class I
- Recalling firm
- Bacai Inc. Dba Ky Duyen House
- Product quantity
- 14,040 softgel capsules
- Termination date
- Feb 10, 2015
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Worldwide via internet sales
- Recall initiation date
- Apr 30, 2014
- Initial firm notification
- Letter
- Center classification date
- Aug 8, 2014