shown on the left and a
counterfeit vial on the right
Photo courtesy of the FDA
The US Food and Drug Administration (FDA) is warning healthcare professionals that a counterfeit version of BiCNU (carmustine for injection) 100 mg has been detected in some foreign countries.
The agency said there is no indication that counterfeit BiCNU has entered the legitimate US drug supply chain and no indication that any US patients have received counterfeit BiCNU.
Still, the FDA is advising that healthcare professionals inspect BiCNU vials as an added precaution to ensure the product administered to patients is authentic.
BiCNU is approved to treat brain cancers, multiple myeloma, and lymphoma. It is manufactured by Emcure Pharmaceuticals Ltd. and distributed in the US by Heritage Pharmaceuticals Inc.
Heritage previously announced that counterfeit BiCNU had been found in India, Ireland, and Israel.
How to identify counterfeit BiCNU
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. The authentic product has a blue flip top, while the counterfeit product may have a gray flip top.
The product may also be counterfeit if the vial displays the following lot numbers, batch numbers, manufacturing dates, and expiration dates.
| Product | Expiration
date |
Manufacturing
date |
Lot number | Batch number |
| BiCNU | 01/18 | 2/16 | BCEM771322 | EM/BC20161990 |
| Diluent | 01/18 | 2/16 | SBCDA224736 | EM/BCD2220 |
| BiCNU | 12/17 | 1/16 | BCEM771318 | EM/BC20151896 |
| Diluent | 12/17 | 1/16 | SBCDA224732 | EM/BCD2216 |
| BiCNU | 10/17 | 11/15 | BCEM771317 | EM/BC20151895 |
| Diluent | 10/17 | 11/15 | SBCDA224731 | EM/BCD2215 |
The FDA urges healthcare professionals to purchase drug products only from legitimate suppliers.
Healthcare professionals are encouraged to report sales solicitation of suspect drug products by calling the FDA’s Office of Criminal Investigations (OCI) at 800-551-3989, reporting via OCI’s website, or emailing DrugSupplyChainIntegrity@fda.hhs.gov.
Healthcare professionals and patients should report adverse events related to the use of any suspect medications to the FDA’s MedWatch Adverse Event Reporting Program.
