Tuberculosis (BCG) vaccine

Urgent medicine recall

20 June 2012
Level: Retail
Class: II
Reference: RC-2012-RN-00543-3
Date agreed: 20 June 2012
Product: Bacillus Calmette-Guérin (BCG) 1.5 mg powder for injection; multidose vial with diluent vial
ARTG number: AUST R 53569
Batch number:
  • C3787AA (Date of Expiry: Aug 2012)
  • C3787AC (Date of Expiry: Dec 2012)
  • C3787AE (Date of Expiry: Feb 2013)
  • C3787AG (Date of Expiry: Feb 2013)
Sponsor: Sanofi-Aventis Australia Pty Ltd trading as Sanofi Pasteur
Customer information: 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)
Reason: 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.

Classification system:

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.