Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe 16%, Lotus Leaf Ext...
FDA Recall #D-1222-2014 — Class I — December 10, 2013
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.
Recalling Firm
Slim Beauty USA — Kearney, NE
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
3 bottles
Distribution
Nationwide
Code Information
Lot # 20130328, Exp 3/27/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated