FDA Warns of Counterfeit Botox

A counterfeit version of Botox was found in the United States, the U.S. Food and Drug Administration (FDA) said in a safety notification dated April 16, 2015. The agency warned that the bogus products may have been sold to doctors’ offices and medical clinics across the country. An unlicensed supplier who is unauthorized to distribute drug products in the US sold the counterfeit product.

Botox products approved by the FDA are manufactured by Allergan and lists “OnabotulinumtoxinA” as the active ingredient on the outer carton and vial. There are some similarities between the fake and FDA-approved products. Healthcare professionals and consumers can identify fake botox products by looking out for a missing lot number on the vial, blank entries next to the LOT: MFG: EXP:, and “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA” as the active ingredient.

Botox is used to treat wrinkles, headaches, severe underarm sweating and other conditions. “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.” the FDA stated in the notification.

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