Counterfeit medicine alert: BiCNU (carmustine for injection) 100mg bottle

Safety advisory

23 May 2016

On 12 May 2016 the United States Food and Drug Administration (FDA) posted an online safety advisory that a counterfeit version of the American approved product BiCNU (carmustine for injection) 100mg had been discovered in some countries outside of the United States.

Information for Australian health care practitioners

  • At this time it appears that the counterfeit BiCNU located is that of the approved label for the United States of America.
  • The counterfeit BiCNU has a grey coloured flip top, the US and Australian approved product has a blue coloured flip top.
  • The US approved product states ‘Rx Only’ where the Australian approved product (bottle and outer box) states PRESCRIPTION ONLY MEDICINE KEEP OUT OF REACH OF CHILDREN.
  • The Australian approved product (bottle and outer box) contains the unique ARTG Registration Number AUSTR 19243.
    In the unlikely event a counterfeit version of BiCNU is located, please contact the TGA as soon as possible.

Counterfeit US label of BiCNU
Photo of bottle with counterfeit US label of BiCNU

Australian approved (box and label) BiCNU - AUSTR 19243
Photo of Australian approved (box and label) BiCNU - AUSTR 19243

Action the TGA is taking

Given the counterfeit product is NOT of the approved Australian label and the obvious differences between the two products, it is unlikely that the counterfeit product will enter the Australian market.

The TGA is notifying health care practitioners, hospital pharmacies and compounders of the counterfeit product and asks everyone to be vigilant.

The TGA will be working with the Australian Border Force (ABF) to help detect any possible shipments of counterfeit BiCNU from entering Australia.

The TGA is advising health care practitioners and consumers to exercise extreme caution if they are considering purchasing medicines from unknown overseas Internet sites. Products purchased over the Internet:

  • may contain undisclosed and potentially harmful ingredients
  • may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.

Information about BiCNU

BiCNU (carmustine for injection) 100mg bottle is an approved registered medicine in Australia and is included in the Australian Register of Therapeutic Goods (ARTG) and is issued Australian Registration Number AUSTR 19243. BiCNU is registered in the ARTG to Emcure Pharmaceuticals Pty Ltd of New South Wales.

BiCNU containing carmustine is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:

  1. Malignant Glioma.
  2. Multiple Myeloma: In combination with prednisone.
  3. Hodgkin's Disease: As secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.
  4. Non-Hodgkins lymphomas: As secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy or who fail to respond to primary therapy.

Report counterfeit medicines and medical devices

If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA:

Phone: 1800 020 653
Online: Report a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products
Email: info@tga.gov.au