The FDA is warning about some counterfeit Botox that has been found in the United States. The product looks similar to the brand name product but “[B]oth 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”
FDA is warning that the counterfeit product was sold by an unlicensed supplier to doctor’s offices and medical clinics. FDA is warning not to use the product and that the Agency states the 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 full warning can be viewed here, along with comparative pictures of the approved and tainted products.
“FDA is asking the public to report suspect Botox products to FDA:
- Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989, or
- Report to OCI at www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm, or
- Email – DrugSupplyChainIntegrity@fda.hhs.gov“
This is not the first time that suspect Botox product has been found in the supply chain. In 2012, the FDA alerted medical practitioners through a warning published on its website, with a link to the letter FDA sent to healthcare providers (which can be found here).
Pharmacies, medical clinics, and healthcare providers should be wary of unknown suppliers that offer products outside of the normal channels of distribution. Or if there appears to be a delay that is too good to be true, then it probably is.