FDA warns of bogus Botox

Fraudulent versions of Botox not approved by the FDA are being sold to medical practices, according to a recent warning to health care practitioners and the public.

“These fraudulent products are considered unsafe and should not be used,” the FDA stated in a press release.

The product is in a counterfeit outer carton, and the vial inside is labeled as a foreign version of Botox, the FDA reported. The product is not FDA-approved for sale in the United States.

The company selling the fraudulent products uses the names “Online Botox Pharmacy,” “Onlinebotox.com” and “Onlinebotox.” “Blast faxes” are being used to solicit sales from medical practices, typically offering prices less than those of FDA-approved products, according to the release. While the product comes from foreign sources, the company is using a US return address when sending packages to medical practices.

Allergan-manufactured Botox for injection (100 units/vial) displays the active ingredient as OnabotulinumtoxinA on the outer box and vial. The FDA does not believe Allergan’s product is at risk.

The fraudulent products have outer cartons displaying 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, the FDA reported. The agency reported that the following examples are fraudulent:

Lot number: C3016 C3 (carton); expiration date, 10-2014
Lot number: C3121 C3 (vial); expiration date, 04-2015
Lot number: C3060 C3 (carton); expiration date, 01-2015
Lot number: C3121 C3 (vial); expiration date, 04-2015

The public should report suspect Botox products to the FDA. Health care professionals and patients are asked to report any adverse events related to the use of suspect medications to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.