Why it was recalled
Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.
Product description
NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056, Bethesda, MD 20827.
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Nationwide
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-0675-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 5, 2015
- FDA report date
- Feb 24, 2016
- Quantity
- 6000 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Inaffit, LLC
Original FDA data
Every field from FDA enforcement report D-0675-2016, exactly as published.
Show all FDA fields
- City
- Gaithersburg
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 72614
- Address
- 356 Urban Ave
- Code information
- All lots
- Postal code
- 20878-4054
- Report date
- Feb 24, 2016
- Product type
- Drugs
- Recall number
- D-0675-2016
- Classification
- Class I
- Recalling firm
- Inaffit, LLC
- Product quantity
- 6000 Bottles
- Termination date
- Mar 14, 2016
- Reason for recall
- Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056, Bethesda, MD 20827.
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 5, 2015
- Initial firm notification
- Center classification date
- Feb 17, 2016