Infanrix hexa vaccine
Medicine recall
11 October 2012
| Level: | Retail | ||||||||||||||
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| Class: | II | ||||||||||||||
| Reference: | RC-2012-RN-01025-1 | ||||||||||||||
| Date agreed: | 10 October 2012 | ||||||||||||||
| Product: | Infanrix hexa vaccine | ||||||||||||||
| ARTG number: | AUST R 132881 | ||||||||||||||
| Batch number: |
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| Sponsor: | GlaxoSmithKline Australia Pty Ltd | ||||||||||||||
| Patient information: | There are no safety concerns for children who have received a dose from the above batches. If your child has received a dose from one of the identified batches, he or she does not need additional monitoring and does not need to be re-vaccinated. Please refer to the TGA's safety alert for more information: Infanrix hexa vaccine. | ||||||||||||||
| Contact: | GlaxoSmithKline Australia has provided a contact number for further information. The telephone number is 1800 064 162. | ||||||||||||||
| Reason: | This precautionary recall is being undertaken because a surface in the area where one of the manufacturing steps for the vaccine takes place was found to have a small amount of contamination with the bacterium Bacillus cereus, an organism commonly found in food and soil. No contamination of the ingredients or in the vaccine itself was found and all the batches subsequently passed the quality and sterility testing required to be released for use in Australia. |
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.
Content last updated: Thursday, 11 October 2012
Web page last updated: Thursday, 11 October 2012
URL: http://www.tga.gov.au/safety/recalls-medicine-infanrix-121011.htm