The Food and Drug Administration (FDA) is informing that a counterfeit version of BiCNU (carmustine for injection; Heritage) 100mg has been identified in some foreign countries. BiCNU, an alkylating agent, is indicated for the treatment of various brain cancers, multiple myeloma, and lymphoma (Hodgkin’s and non-Hodgkin’s).
BiCNU is packaged as a vial of BiCNU and dehydrated alcohol. Though the NDC number on the outer package of the authentic and counterfeit versions may be the same, the counterfeit version can be identified by looking at the BiCNU vial inside the packaging. In addition, the BiCNU vial may be counterfeit if the vial displays the lot #, batch #, manufacturing dates, and expiration dates as listed on the FDA website.
Further, the authentic product has a blue flip top whereas the counterfeit product has a gray flip top. The NDC number on the authentic BiCNU vial should end with “-31” and not “-41.”
Healthcare professionals are urged to carefully examine the BiCNU vial to ensure that the authentic product is being administered. Drug products should only be purchased from legitimate suppliers and any solicited sales of suspect drug products should be reported to the FDA’s Office of Criminal Investigations (OCI).
At this time, there is no sign that counterfeit BiCNU has entered the U.S. drug supply chain or that any U.S. patients have received counterfeit BiCNU.
For more information call (800) 551-3989 or visit FDA.gov.