Published: 20 June 2012

Safety Information

Urgent Medicine Recall - BCG Vaccine

20 June 2012

Product - BCG Vaccine (Freeze Dried) 1.5mg Powder for Injection Multidose Vial with diluent vial

Batch number on carton and vaccine vial	Expiry
C3787AA	Aug 2012
C3787AC	Dec 2012
C3787AE	Feb 2013
C3787AG	Feb 2013

sanofi-aventis New Zealand Limited is recalling the above mentioned batches of BCG (Bacillus Calmette-Guérin)1.5 mg powder for injection multidose vial with diluent vial.

The above four batches of vaccine are being recalled as a precaution because environmental monitoring at the manufacturing facility indicates that the sterility of the vaccine cannot be assured.

At this stage manufacturing of the BCG Vaccine has been halted. Supply will recommence when Medsafe is satisfied that corrective actions have successfully been implemented.

There is currently no replacement stock available at the manufacturing site and there will be no supply of BCG vaccine in New Zealand until a replacement is found.

Potential alternative suppliers of BCG vaccine are being sought.

A known side effect of this vaccine is local redness, mild swelling and possible fever. There has been no increase in the number of reports of adverse events from this vaccine reported to CARM (Centre for Adverse Reaction Monitoring) since this vaccine has been on the market.

Up to 7000 doses have been distributed since November 2011. Not all of these doses will have been given. Most of the recipients will be children under five in populations exposed to Tuberculosis (TB) through family or former country of residence.

Anyone who has received this vaccine does not need to take any action due to the recall. If you are concerned, please talk to your GP or a health professional.

Company contact:

Sanofi Pasteur Medical Information freephone 0800 727 838 (0800PASTEUR).

For information on returning affected stock:

Please call Customer Services at Healthcare Logistics on freephone 0800 726 634 (0800SANOFI).

Additional Information:

Ministry of Health fact sheet

http://www.health.govt.nz/news-media/news-items/tuberculosis-bcg-vaccine-recall

Links are included below to additional information which has been published by Health Canada and the Department of Health and Ageing in Australia as this product has also been recalled in these markets.

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_97-eng.php

http://www.health.gov.au/internet/main/publishing.nsf/Content/bcg-factsheet.htm

http://www.tga.gov.au/safety/recalls-medicine-tuberculosis-bcg-vaccine-120620.htm