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FDA Warns of Counterfeit Botox Found in the US   May . 4 . 2015

The Food and Drug Administration (FDA) recently announced that a counterfeit version of Botox has been found in the United States. The product, which may have been sold to offices and clinics nationwide, was sold by an unlicensed, unauthorized supplier. The FDA warns healthcare providers against using these unverified drugs, and provides a way to easily identify if a batch is from this unlicensed provider.

According to the FDA Drug Safety Alert, “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’ ”

Please note that, at present, there is no reason to believe that Allergan’s FDA-approved Botox is at risk, and “the genuine product should be considered safe and effective for its intended and approved uses.” Suspicious packages of Botox should be reported to the FDA’s Office of Criminal Investigations.

For more information, and to stay up to date with Drug Safety Alerts, please visit

Information for this blog post was sourced from NABP e-News and the FDA Drug Safety Alert. For more information about the National Association Board of Pharmacy, please visit



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