LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos…
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
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 Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.
What was recalled
LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com
- Recalling firm
- Lipo Escultura Corp.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0860-2016
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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