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# FDA: No Counterfeit BiCNU Detected in U.S.
- URL: https://www.fdaweb.com/fda-no-counterfeit-bicnu-detected-in-u-s/
- Published: 2016-05-13T12:00:00.000Z
- Updated: 2026-09-14T21:02:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135674

FDA says that so far there is no indication that counterfeit drug product labeled as BiCNU (carmustine for injection) 100 mg has entered the legitimate U.S. drug supply chain, or that any U.S. patients have received any of the suspect product. Earlier this week, Heritage Pharmaceuticals said ([see story](https://www.fdaweb.com/counterfeit-bicnu-outside-u-s-heritage-says/)) it had become aware of the existence of a counterfeit BiCNU that is being sold and distributed outside of the U.S.

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 U.S. by Heritage.

A just-posted agency drug safety alert advises health care professionals to carefully inspect the BiCNU vial as an added precaution to ensure the product administered to patients is authentic.