Bacillus Calmette-Guérin (BCG) 1.5 mg powder for injection; multidose vial with diluent vial
AUST R 53569
C3787AA (Date of Expiry: Aug 2012)
C3787AC (Date of Expiry: Dec 2012)
C3787AE (Date of Expiry: Feb 2013)
C3787AG (Date of Expiry: Feb 2013)
Sanofi-Aventis Australia Pty Ltd trading as Sanofi Pasteur
Manufacturing of the BCG vaccine has been halted, supply will only recommence when TGA is satisfied that corrective actions to the manufacturing site have successfully been implemented. There may be a potential shortage of BCG vaccine in Australia in the interim. Possible alternative suppliers of BCG vaccine are being investigated by TGA and Sanofi-Aventis Australia Pty Ltd. Please refer to the BCG vaccine fact sheet for more details about the management of patients during this time.
For medical information, please contact Sanofi Pasteur Medical Communications at 1800 818 806.
For returning stock or affected batch details, contact Sanofi Pasteur customer service on 1800 152 416 (9:00 am. to 5:00 pm Standard Eastern Australian Time)
The product is being recalled due to problems with the program for monitoring for environmental contamination at the manufacturing premises in Canada, which means that there is a theoretical risk to the sterility of the product.
Class I defects are potentially life-threatening or could cause a serious risk to health.
Class II defects could cause illness or mistreatment, but are not Class I.
Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.
Class I & II recalls are considered to be safety related recalls.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.