FDA warns that missing and mislabeled information on vial and carton are indicators of counterfeit product, which is considered unsafe and should not be used. Agency urges docs to confirm their distributor is authorized.

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”