Why it was recalled
Marketed without an approved NDA/ANDA: Undeclared sibutramine.
Product description
Dream Body Advanced 400 mg 30 capsules in brown foil packets.
Lot numbers, UPCs & expiration codes
All lots.
Where it was sold
United States
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-0108-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 1, 2016
- FDA report date
- Oct 26, 2016
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dream Body Weight Loss
Original FDA data
Every field from FDA enforcement report D-0108-2017, exactly as published.
Show all FDA fields
- City
- Grand Prairie
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 74588
- Address
- 2330 S Belt Line Rd
- Code information
- All lots.
- Postal code
- 75051-4151
- Report date
- Oct 26, 2016
- Product type
- Drugs
- Recall number
- D-0108-2017
- Classification
- Class II
- Recalling firm
- Dream Body Weight Loss
- Product quantity
- Unknown
- Termination date
- Sep 30, 2021
- Reason for recall
- Marketed without an approved NDA/ANDA: Undeclared sibutramine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dream Body Advanced 400 mg 30 capsules in brown foil packets.
- Distribution pattern
- United States
- Recall initiation date
- Jul 1, 2016
- Initial firm notification
- Press Release
- Center classification date
- Oct 19, 2016