From Medscape- 4/2/0/15
A counterfeit version of onabotulinum toxin A (Botox, Allergan) has been found in the United States and may have reached physicians' offices and medical clinics nationwide, the US Food and Drug Administration (FDA) warned on April 16.
"The product was sold by an unlicensed supplier who is not authorized to ship or distribute drug products in the United States. The counterfeit 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 agency said in a news release.
The FDA is not aware of any adverse events associated with the counterfeit version of Botox at this time.
They note that the FDA-approved Botox displays the active ingredient as "onabotulinum toxin A" on the outer carton and vial. On the fake version, the outer carton and vial display the active ingredient as "botulinum toxin type A."
Also, on the counterfeit product, the vial may be missing the lot number and the outer carton may not have any entries next to the LOT, MFG, and EXP categories.
"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," the FDA said.
The FDA said health providers should check with Allergan to make sure that the distributor they purchase from is authorized to distribute Botox. A list of authorized Botox suppliers is available on Allergan's website.
The FDA is asking the public to report suspect Botox products by calling the FDA's Office of Criminal Investigations at 800-551-3989, online at http://www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm, or by email at [email protected].
The FDA encourages health care professionals to report adverse events related to the use of any suspect medications to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.