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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.
- PageAustralian Recall Coordinator notification listFor each recall action, the Australian Recall Coordinator forwards, in writing by email, a notice to the relevant parties
- PageRecall coordinators for therapeutic goodsRecall coordinators play an important part in the uniform recall procedure for therapeutic goods