 |
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
FDA is alerting health care practitioners and the public that a counterfeit version of Botox was found in the United States and may have been sold to doctors’ offices and medical clinics nationwide. The product was sold by an unlicensed supplier who is not authorized to ship or distribute drug products in the United States.
The counterfeit products are considered unsafe and should not be used. FDA cannot confirm that the manufacture, quality, storage, and handling of these suspect products follow U.S. standards.
There are some similarities between the counterfeit Botox products and the FDA-approved Botox for injection (100 units/vial), manufactured by Allergan. The FDA-approved Botox displays the active ingredient as “OnabotulinumtoxinA” on the outer carton and vial. Currently, there is no indication that Allergan’s FDA-approved version is at risk, and the genuine product should be considered safe and effective for its intended and approved uses.
For more information please visit: Botox
This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO FDA (1-888-463-6332) or (301) 796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at druginfo@fda.hhs.gov.
- For additional drug information, please visit the DDI Web page.
- For up-to-date drug information, follow the FDA’s Division of Drug Information on Twitter: FDA_Drug_Info.
- This service is provided to you at no charge by the U.S. Food & Drug Administration (FDA).
No hay comentarios:
Publicar un comentario