D-0860-2016 Class I Terminated
FDA drug recall D-0860-2016 was initiated by Lipo Escultura Corp. on December 3, 2015 and is designated Class I. 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 Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market i… The recall status is terminated (terminated April 17, 2017). Affected quantity: unknown.
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 Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.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