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FDA Cracks Down on Lipodissolve Procedures
Posted: April 8, 2010
page 3 of 3
The FDA is requesting a written response from these U.S. companies within 15 business days of receipt of the letters stating how they will correct these violations and prevent similar violations in the future. These firms were told that failure to promptly correct the violations may result in legal action.
The Brazilian firm getting a warning letter markets lipodissolve products on two Web sites: zipmed.net and mesoone.com. The FDA will notify regulatory authorities in Brazil of this action. The agency has issued an import alert against the zipmed.net and mesoone.com entities to prevent the importation and distribution of unapproved lipodissolve drug products into the United States. Importing and distributing unapproved drug products is a violation of the Federal Food, Drug, and Cosmetic Act.
How to report side effects
Consumers and health care professionals may report serious side effects with the use of lipodissolve products to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.
Online: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm4. By regular mail: Use postage-paid, pre-addressed FDA form 35005. By fax: 800-FDA-0178. By phone: 800-FDA-1088.
This article appears on the FDA's Consumer Updates, Page 6, which features the latest on all FDA-regulated products.