The Recall Desk
CriticalFDA (Drugs)·D-0860-2016·Announced 2016-06-01

Lipo Escultura capsules recalled for containing unapproved prescription drugs

Lipo Escultura capsules are being recalled because they contain sibutramine and diclofenac, making them unapproved drugs rather than dietary supplements.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Lipo Escultura Corp. is recalling Lipo Escultura capsules, 250 mg, 60-count bottles. The product was distributed by JAT Productos Naturales Corp. in Brooklyn, NY, and sold nationwide via the Internet. All lots are affected.

The FDA determined that the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Although marketed as a dietary supplement, the product was found to be tainted with sibutramine, an appetite suppressant withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug. Consequently, the product is considered an unapproved drug.

Consumers who purchased Lipo Escultura capsules should stop using the product and contact the distributor or manufacturer for further instructions.

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots

Distribution

Distributed nationwide across the United States.