D-1222-2014 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 16, 2014
- Initiation Date
- December 10, 2013
- Termination Date
- March 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 bottles
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).
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.
Distribution Pattern
Nationwide
Code Information
Lot # 20130328, Exp 3/27/15