Photo courtesy of the FDA; http://www.fda.gov/Drugs/DrugSafety/ucm500705.htm
The FDA is alerting professionals of a counterfeit of the drug BiCNU (carmustine for injection) 100 mg, which has been detected in some foreign countries.
At this time, the FDA said that there is no indication that the “counterfeit BiCNU has entered the legitimate U.S. drug supply chain and no indication that any U.S. patients have received counterfeit BiCNU.”
The FDA is currently recommending professionals carefully inspect the BiCNU vial prior to administration to ensure the product’s authenticity. “While the NDC on the outer package of the authentic and counterfeit versions might match,” said the FDA on its website, “the best way to distinguish a counterfeit is to look at the BiCNU vial inside the packaging.”
However, if the vial displays the following lot numbers, batch numbers, manufacturing dates, and expiration dates, the product may also be counterfeit:
Photo courtesy of the FDA; http://www.fda.gov/Drugs/DrugSafety/ucm500705.htm
About BiCNU:
- Approved to treat different types of brain cancer, multiple myeloma, and lymphoma (Hodgkin’s and non-Hodgkin’s)
- Manufactured by Emcure Pharmaceuticals Ltd.
- Distributed in the United States by Heritage Pharmaceuticals Inc.
- Available as a vial of BiCNU and dehydrated alcohol co-packaged together
To learn more or to report suspect drug products, click here.
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