Other safety alerts
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| The United States: FDA advises health care professionals that counterfeit BiCNU has been discovered in some foreign countries |
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The Food and Drug Administration (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.
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.
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. 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. Details of identifying information for the counterfeit lots that have been reported to the FDA can be found at the FDA website.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm500705.htm
In Hong Kong, BiCNU for Inj 100mg (HK-05144) is a pharmaceutical product registered by Hind Wing Co Ltd (Hind Wing), and is a prescription only medicine. So far, the Department of Health (DH) has not received any adverse drug reaction case related to the product. As confirmed with Hind Wing, the company has not imported any product with the concerned batch numbers into Hong Kong, and is not aware of any report of the counterfeit product in the local market. DH will continue to remain vigilant on the development of the issue.
Ends/ Monday, May 16, 2016
Issued at HKT 16:00
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