BiCNU (carmustine for injection): FDA Alert - Counterfeit Product Discovered in Some Foreign Countries

AUDIENCE: Health Professional, Pharmacy, Oncology

ISSUE: FDA is informing health care professionals that a counterfeit version of the FDA approved cancer drug, BiCNU (carmustine for injection) 100 mg, has been detected in some foreign countries. There is no indication at this time that counterfeit BiCNU has entered the legitimate U.S. drug supply chain and no indication that any U.S. patients have received counterfeit BiCNU. See the FDA Alert for more information, including product photos and affected lot numbers.

BACKGROUND: The authentic product is approved to treat different types of brain cancer, multiple myeloma, and lymphoma (Hodgkin’s and non-Hodgkin’s). BiCNU is manufactured by Emcure Pharmaceuticals Ltd. and distributed in the United States by Heritage Pharmaceuticals Inc.

BiCNU is available as a vial of BiCNU and dehydrated alcohol co-packaged together. While the NDC on the outer package of the authentic and counterfeit versions might match, the best way to distinguish a counterfeit is to look at the BiCNU vial inside the packaging.

RECOMMENDATION: The FDA is advising health care professionals to carefully inspect the BiCNU vial as an added precaution to ensure the product administered to patients is authentic.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the MedWatch safety alert, including a link to the FDA Alert statement, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm500910.htm