Be vigilant of counterfeit version of Botox found in United States

April 20, 2015

A counterfeit version of onabotulinumtoxinA (Botox) was found in the United States and may have been sold to doctors’ offices and medical clinics nationwide. The version is considered unsafe and should not be used.

A counterfeit version of onabotulinumtoxinA (Botox) was found in the United States and may have been sold to physicians’ offices and medical clinics nationwide. This version is considered unsafe and should not be used.

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The product was sold by an unlicensed supplier who is not authorized to ship or distribute drug products in the United States. FDA cannot confirm that the manufacture, quality, storage, and handling of these suspect products follow US standards.

Grayson“All parties in the supply chain should be vigilant for counterfeit medicines,” said Mark Grayson, deputy vice president, PhRMA. “They should only purchase medicines from licensed suppliers that are part of the legitimate supply chain in the United States. If they suspect that there is a problem they need to alert FDA immediately.”

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.

Both the outer carton and vial on the suspect product are counterfeit. The counterfeit product can be identified by one or more of the following:

  • the vial is missing the lot number

  • the outer carton does not have any entries next to the LOT: MFG: EXP:

  • the outer carton and vial display the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA”

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In a statement Allegan said: "In an effort to combat illegal product importation, Allergan takes many steps to ensure that the Botox Cosmetic or Botox that is distributed to our customers for patient use is safe and effective.  For instance, only authentic Botox Cosmetic and Botox vials have a sophisticated hologram image that says “Allergan.” The Botox Cosmetic and Botox box will also indicate if the product is packaged for use in the United States by a U.S. License Number that is located on a side panel. The U.S. License number is also located on the product vial. Physicians can learn more about how to identify authentic Botox Cosmetic and can report suspected illegal importation activity by visiting: www.authenticbotoxcosmetic.com."

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Botox is not the only prescription drug that is subject to counterfeiting activities, but it may be the most concerning,” said John Santilli partner, Access Market Intelligence, in Trumbull, Conn. Santilli points out that the active ingredient in Botox is carefully controlled and regulated for safe use. Unapproved deviations in ingredients and suppliers could lead to serious health hazards for patients. 

 

Authentic Vial (courtesy of fda.gov)

Counterfeit Package (courtesy of fda.gov)

Counterfeit Vial (courtesy of fda.gov)

Counterfeit Vial (courtesy of fda.gov)