Federal health officials are warning doctors and patients that a counterfeit version of Botox has made its way into the U.S. market.
The FDA says the fake drug may have been sold to medical practices nationwide by a supplier who was not authorized to distribute pharmaceuticals in this country.
Because regulators cannot confirm that the manufacturing, quality control, storage or handling of the counterfeit Botox meets U.S. safety standards, the FDA says it should be considered unsafe and should not be used.
So far, the FDA says it has not received any reports of patients suffering harm from the counterfeit drug.
Botox, a purified form of the botulinum toxin, is commonly used as a cosmetic treatment, injected into the face to smooth out wrinkles. It can also be used for medical purposes to treat chronic migraines, muscle spasms and other conditions.
Officials say the fake Botox can be spotted by one or more of these errors on the label:
- 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"
The FDA advised doctors to check with Botox's manufacturer, Allergan, to make sure that their supply was purchased from an authorized distributor.