sábado, 5 de diciembre de 2015

FDA MedWatch - Lipo Escultura: Recall - Undeclared Drug Ingredients

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Lipo Escultura: Recall - Undeclared Drug Ingredients

AUDIENCE: Consumer
ISSUE: Lipo Escultura Corp. of Brooklyn, NY (dba JAT Productos Naturales Corp., and JAT Natural Products Corp.) are voluntarily recalling all Lipo Escultura within expiry to the consumer level. The Lipo Escultura capsules were tested by the FDA and have been found to contain sibutramine and diclofenac.
Sibutramine is an appetite suppressant now a controlled substance that was removed from the market for safety reasons. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDS may cause increased risk of cardiovascular events, such as heart attack and stroked, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines.
BACKGROUND: Lipo Escultura is marketed as a weight loss dietary supplement.  Products were sold/distributed Nationwide by JAT Productos Naturales Corp. via internet sales onwww.lipoesculturatreatment.com, through Lipo Escultura Corp. 888 Wyckoff Ave. Brooklyn, NY 11237, a retail store, and 1360 Hancock Street, Brooklyn, NY 11237, a home office.
RECOMMENDATION: Immediately discontinue the use of this product. Consumers with questions should contact Julio Tapia at (718) 415-2611 or (347) 867-9988 Monday through Friday from 9am to 5pm Eastern Standard Time.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Press Release, at:

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