| 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: |
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| 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. |
| Contact: |
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| 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.