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Tuberculosis (BCG) vaccine
Urgent medicine recall
|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|
|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.|
|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.|
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.