FDA Recall D-0860-2016
Lipo Escultura Corp. · Brooklyn, NY
Class I — life-threatening Terminated 501 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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 Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.
Recall record
- Recall number
D-0860-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide via Internet sales
- Recall initiated
- 2015-12-03
- Classified by FDA Center
- 2016-05-23
- FDA published
- 2016-06-01
- Terminated
- 2017-04-17
- Recalling firm
- Lipo Escultura Corp.
- Firm location
- Brooklyn, NY