| Type of Product |
Medicine |
| TGA Recall Reference |
RC-2015-RN-01081-1 |
| Product Name/Description |
Chlorhexidine and Cetrimide irrigation solution 30mL Steritube ampoules (chlorohexidine gluconate 0.05%w/v and cetrimide 0.5%w/v)
Batch Number: M18113
Aust R Number: 57011 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
The sterility assurance of Chlorhexidine and Cetrimide Irrigation Solution has been compromised. The integrity of the sterilising filter used in the filing of Batch M18113 has failed integrity testing and the affected batch was erroneously distributed to the Australian Market.
No adverse events or product complaints have been received.. |
| Recall Action |
Recall |
| Recall Action Instructions |
A consumer level Recall is proposed under the current distribution information however in the event that in the coming days the remainder of warehouses confirm only hospitals and Doctors surgeries have been supplied then the Recall Action will be reduced to hospital level in order to match the recall level with the level of distribution of the affected batch. This action has been clsoed-out on 22/08/2016. |
| Contact Information |
1800 675 229 - Medical Information Service |