LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com
Reported: June 1, 2016 Initiated: December 3, 2015 #D-0860-2016
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 Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.
Details
- Recalling Firm
- Lipo Escultura Corp.
- Units Affected
- unknown
- Distribution
- Nationwide via Internet sales
- Location
- Brooklyn, NY
Frequently Asked Questions
What product was recalled? ▼
LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com. Recalled by Lipo Escultura Corp.. Units affected: unknown.
Why was this product 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 Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 1, 2016. Severity: Critical. Recall number: D-0860-2016.
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