D-0860-2016 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 1, 2016
- Initiation Date
- December 3, 2015
- Termination Date
- April 17, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
Product Description
LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com
Reason for Recall
Marketed Without An Approved NDA/ANDA: Tainted product marketed as a dietary supplement. Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.
Distribution Pattern
Nationwide via Internet sales
Code Information
All lots