An unapproved medicine is being distributed as bevacizumab by Medical Device King, a U.S.-based company also known as Pharmalogical and Taranis Medical, the Food and Drug Administration has announced.
Tests have confirmed that there is no active ingredient in at least one batch of the counterfeit version of Roche’s Altuzan 400 mg/16 mL, an injectable version of bevacizumab that is not approved in the United States.
Avastin (Genentech) is the only FDA-approved version of bevacizumab for sale in the United States.
The FDA is advising practices to stop using any medical products that may have been obtained from Medical Device King, Pharmalogical, and Taranis Medical and to contact FDA’s Office of Criminal Investigations to arrange for the collection of these products.
To report suspect products obtained from Medical Device King, Pharmalogical, Taranis Medical, or other questionable sources, contact the FDA’s Office of Criminal Investigations at 800-551-3989, www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm, or via e-mail to DrugSupplyChainIntegrity@fda.hhs.gov.