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FDA alerts public of counterfeit Botox found in US

A counterfeit version of Botox has been found in the U.S. and may have been sold to health practitioners nationwide, according to an alert issued by the FDA.

The FDA warned that, although there are some similarities between the counterfeit Botox (onabotulinumtoxinA, Allergan) and the FDA-approved product for injection (100 units/vial), the counterfeit product is considered unsafe and should not be used.

Both the outer carton and the vial on the product are counterfeit. The vial is missing the lot number and the outer carton does not have any entries next to the LOT:, MFG:, or EXP: spaces on the back or side of the carton. Additionally, the outer carton displays the active ingredient as “Botulinum Toxin Type A” instead of “onabotulinumtoxinA.”

Health professionals should verify that the distributor they purchase from is authorized to distribute onabotulinumtoxinA, according to the FDA alert.

The FDA encourages health professionals and the public to report suspected counterfeit products. 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, according to the alert.

Reference: www.fda.gov.