Carmustine (BiCNU) – Counterfeit Product
May 16, 2016
FDA issued a safety alert notifying health care professionals and patients of counterfeit BiCNU (carmustine) 100-mg vials. The counterfeit products were found in foreign countries. These products have yet to be reported in the US supply chain. The counterfeit products look very similar to authentic product, but may have a gray flip top and may have -41 as the last 2 digits of the NDC on the vial. The following lot numbers, batch numbers, and manufacturing and expiration dates may also be listed on the counterfeit products:
- BiCNU: Expiration date 01/18; Manufacturing date 02/16; Lot# BCEM771322; Batch# EM/BC20161990
- Diluent: Expiration date 01/18; Manufacturing date 02/16; Lot# SBCDA224736; Batch# EM/BCD2220
- BiCNU: Expiration date 12/17; Manufacturing date 01/16; Lot# BCEM771318; Batch# EM/BC20151896
- Diluent: Expiration date 12/17; Manufacturing date 01/16; Lot# SBCDA224732; Batch# EM/BCD2216
- BiCNU: Expiration date 10/17; Manufacturing date 11/15; Lot# BCEM771317; Batch# EM/BC20151895
- Diluent: Expiration date 10/17; Manufacturing date 11/15; Lot# SBCDA224731; Batch# EM/BCD2215
Authentic FDA-approved BiCNU (carmustine) products are manufactured by Emcure Pharmaceuticals, distributed by Heritage Pharmaceuticals, and packaged with dehydrated alcohol diluent. The last 2 digits of the NDC are -31, and the product has a blue flip top. FDA recommends closely inspecting the vial prior to use.
FDA recommends the purchase of drug products from legal suppliers only. Report suspicious or counterfeit products to FDA's Office of Criminal Investigations (OCI) at 800-551-3989, OCI's Web site www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm, or email DrugSupplyChainIntegrity@fda.hhs.gov.
Report any related adverse events to FDA’s MedWatch Adverse Event Reporting program online at
Additional information is available at the following links:
- FDA MedWatch – May 2016
- FDA Statement: FDA advises health care professionals that counterfeit BiCNU has been discovered in some foreign countries (includes pictures of counterfeit product and counterfeit lot numbers) – May 2016
May 16, 2016; University of Utah, Drug Information Service. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.