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Recall procedure
Print version
See: URPTG
Uniform recall procedure for therapeutic goods, V2.2
We encourage sponsors to follow this procedure to decide, in consultation with us, to take the most appropriate action (recall or non-recall) to mitigate an actual or potential public health risk from a particular good.
However, a TGA delegate of the Secretary of the Australian Government Department of Health (the Secretary) can exercise powers under the Therapeutic Goods Act 1989 (the Act) to mandate the sponsor to recall therapeutic goods to protect public health.
Don't make the mistake of determining the action to take (recall or non-recall) without going through this procedure and obtaining our agreement.
Which steps to follow
Type of recall | Steps to follow |
---|---|
Immediate recalls | 1 and other steps if required |
Other recalls | 2 to 11 |
Non-recall actions | 2 to 4; 6 to 11 as applicable |
Product tampering | 1 |
Note
This recall procedure does not apply to blood recalls triggered by Single Donor Notifications (e.g. report of a post-donation illness). The Blood Service also provides a compiled list to the TGA on a monthly basis, broken down into common categories.
Recall pathways (flowchart)
Immediate recalls (from Step 1)
Immediate recalls start from Step 1, because it's critical you contact the Australian Recall Coordinator and customers earlier than normal.
The flowchart shows who needs to be contacted (and in what order) for each case. After this initial part of the recall procedure, ensure you follow the remaining steps (Steps 2 to 11).
Step 1
-
Immediate and significant threat
- Contact the Australian Recall Coordinator
- Implement and report on the agreed recall strategy
Actual (or potential) product tampering
- Contact the Australian Recall Coordinator
- Implement and report on the agreed recall strategy
Human blood or a blood component
- Contact the Australian Recall Coordinator
- Get TGA recalls reference number
- Contact customers
- Implement and report on the agreed recall strategy
Biologicals
- Contact customers
- Contact the Australian Recall Coordinator
- Implement and report on the agreed recall strategy
Radiopharmaceuticals
- Contact customers
- Contact the Australian Recall Coordinator
- Implement and report on the agreed recall strategy
All other recalls (from Step 2)
Determining the action to take
Step 2 | Obtaining distribution and stock status |
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Step 3 | Conducting a risk analysis |
Step 4 |
Deciding the type, class, and level of recall You can contact the TGA for help with deciding if a recall is needed. For non-recall actions, skip to Step 6 (Drafting a communication strategy). |
Recalling the goods
Step 5 | Developing a recall strategy |
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Step 6 | Drafting a communication strategy |
Step 7 | Submitting recall information |
Step 8 |
If the TGA and the sponsor cannot reach agreement at this step, the TGA has the option to mandate a recall. |
Step 9 | Implementing the recall |
Step 10 |
Provide recall progress reports, including root cause assessment, and corrective and preventative actions (CAPA). |
Step 11 |
The TGA will review the progress reports, and decide if any further actions are required. |