Drug product
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).
D-1222-2014
Product summary
- Firm
- Slim Beauty USA
- Event
- Event 67260
- Status
- Terminated
- Classification
- Class I
- Quantity
- 3 bottles
- Official record key
drug-enforcement:D-1222-2014
Official wording
Reason: 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.
Code information: Lot # 20130328, Exp 3/27/15
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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.