Call Now (225) 766-0005
   Follow Us on Social

Fake Botox found by the FDA!

June 14, 2013

Make sure your doctor is using BOTOX® directly from Allergan!  The only proven safe, effective and legal relaxers are Botox and Dysport.  Price is often an indicator that a provider may be using an illegal product.  If the price seems too good to be true, it probably is.  Dr. Jane uses only legal brand products including Botox and Dysport.  She is ASOPRS Fellowship trained in Facial Plastic Surgery and Non-Surgical procedures and holds a faculty appointment at Yale University.  She has been injecting Botox for over 20 years and was a faulty trainer for Botox teaching other physicians in the proper and effective use of the product.  Training, experience and integrity matter when you are choosing a physician.   Call now to scheudle your consultation.  

More on the use of illegal and fake Botox from the FDA:

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:

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 either:

  • Complete and submit the report online: www.fda.gov/MedWatch/report.htm, or
  • 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. 

FDA has issued a series of alerts and letters to practitioners about the risk of buying medicines from foreign or unlicensed sources. (http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm330610.htm  andhttp://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm299920.htm ) 

The Food and Drug Administration is committed to protecting public health by securing the drug supply chain against counterfeit and unapproved medications that enter the United States through fraudulent sources.

As more information becomes available, this webpage will be updated.

 

Tags:
Newsletter

Subscribe to Dr. Olson's newsletter for the latest updates and specials.

Doctor Olson is board certified and is fellowship trained as an oculofacial plastic surgeon.
Treatments
Location
Jane Olson, MD
8440 Bluebonnet Blvd, Ste B
Baton Rouge, LA 70810
Phone: 225.766.0005
The information available on this web site is provided for informational purposes only. This information is not intended to replace a medical consultation where a physician’s judgment may advise you about specific disorders, conditions and or treatment options. We hope the information will be useful for you to become more educated about your health care decisions.
Copyright © 2021 Jane Olson MD. All Rights Reserved.