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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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marketed as a dietary supplement, the product was found to be tainted with sibutramine, an appetite suppressant withdrawn from the U.S. market in October 2010 for safety reasons, and diclofenac, a prescription non-steroidal anti-inflammatory drug.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
- Manufacturer
- Lipo Escultura Corp.
- Category
- Drug — Dietary Supplement
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.
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