FDA Warns of Fake Botox

Fraudulent Versions of Botox Found in the United States
[04-26-2013] FDA is alerting health care practitioners and the public that fraudulent versions of Botox that are not approved by the FDA are being sold to U.S. medical practices.  The outer carton is counterfeit, while the vial inside is labeled as a foreign version of Botox, which is not FDA-approved for sale in the United States. These products are being sold by unlicensed suppliers who are not part of the legitimate U.S. supply chain. FDA cannot confirm that the manufacture, quality, storage, and handling of these products follow U.S. standards.  These fraudulent products are considered unsafe and should not be used. 

The company selling the fraudulent versions of Botox goes by the names “Online Botox Pharmacy,” “Onlinebotox.com,” and “Onlinebotox.” At the time this alert was issued, the company did not appear to be selling its products over the internet. Instead, the company has been using “blast faxes” to solicit sales from medical practices, typically selling products at prices below those of FDA-approved products. As is the case with many companies that sell fraudulent products, Online Botox Pharmacy uses a U.S. return address when sending packages to medical practices, even though the products are from foreign sources.

Medications purchased from foreign or unlicensed sources may be misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe.  Medical practices that purchase and administer illegal and unapproved medications from foreign sources are putting patients’ health at risk, as patients may not be getting proper treatment.

FDA-approved Botox for injection (100 units/vial), manufactured by Allergan, 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 this product should be considered safe and effective for its intended and approved uses.

Suspect fraudulent products can be identified as follows:

the outer carton displays the active ingredient as “Botulinum Toxin Type A”; or
the lot numbers and expiration dates on the outer carton and accompanying vial do not match.
 
Thus far, the following examples have been confirmed as fraudulent Botox. Products with any of these lot numbers and expiration dates should be considered suspect.

Example 1

Lot #    Exp Date
C3016 C3 (carton) 10-2014      
C3121 C3 (vial)    04-2015 

Example 2

Lot #    Exp Date
C3060 C3 (carton) 01-2015   
C3121 C3 (vial)    04-2015

FDA is asking the public to report suspect Botox products obtained from Online Botox Pharmacy or other questionable sources:

Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989, or 
Report to OCI by email - DrugSupplyChainIntegrity@fda.hhs.gov
Health care professionals and patients should report adverse events related to the use of any suspect medications to FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail, by fax, or by phone. Health care professionals and consumers can download form3 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.

Posted: April 2013


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