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Recall Observatory FDA recall evidence

Drug product

LIPO ESCULTURA capsules, 250 mg, 60-count bottles, Distributed By: JAT Productos Naturales Corp., BROOKLYN, NY 11238, www.lipoesculturatreatment.com

D-0860-2016

December 03, 2015

Class I

Product summary

Firm
Lipo Escultura Corp.
Event
Event 72782
Status
Terminated
Classification
Class I
Quantity
unknown
Official record key
drug-enforcement:D-0860-2016

Official wording

Reason: 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 Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.

Code information: All lots

Distribution pattern: Nationwide via Internet sales

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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 Product found to be tainted with sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug, making this an unapproved drug.