D-1222-2014 Class I Terminated

Recalled by Slim Beauty USA — Kearney, NE

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