Why it was recalled
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently marketed in the United States, making this product an unapproved new drug.
Product description
Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe 16%, Lotus Leaf Extract 12%, Medical Amylum 30%), 350 mg, 30-count bottles, Made in China (Beijing).
Lot numbers, UPCs & expiration codes
Lot # 20130328, Exp 3/27/15
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-1222-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 10, 2013
- FDA report date
- Apr 16, 2014
- Quantity
- 3 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Slim Beauty USA
Original FDA data
Every field from FDA enforcement report D-1222-2014, exactly as published.
Show all FDA fields
- City
- Kearney
- State
- NE
- Status
- Terminated
- Country
- United States
- Event ID
- 67260
- Address
- 503 E 23rd St
- Code information
- Lot # 20130328, Exp 3/27/15
- Postal code
- 68847
- Report date
- Apr 16, 2014
- Product type
- Drugs
- Recall number
- D-1222-2014
- Classification
- Class I
- Recalling firm
- Slim Beauty USA
- Product quantity
- 3 bottles
- Termination date
- Mar 14, 2017
- Reason for recall
- Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently marketed in the United States, making this product an unapproved new drug.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe 16%, Lotus Leaf Extract 12%, Medical Amylum 30%), 350 mg, 30-count bottles, Made in China (Beijing).
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 10, 2013
- Initial firm notification
- Center classification date
- Apr 7, 2014