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Recall procedure

Uniform recall procedure for therapeutic goods, V2.2

12 December 2019

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Step 4. Deciding the type, class and level of recall

Check whether the issue with your therapeutic good(s) requires a recall before you consider a non-recall action.

Check you need to conduct a recall

Using the information gathered in Steps 2 and 3 go to Recalls and non-recall actions and follow the guide. This will assist you to decide the:

  1. type of recall
  2. class of recall
  3. level of recall

Check your role as a sponsor for undertaking a recall.

Ask your TGA Business Services administrator to update your recall contact details.

Need help

Contact us if you need help.

Part of our role is to undertake an independent assessment of the risks and ensure that recalls are conducted when appropriate.

You have a recall?

If after completing this assessment, you think you have a recall:

  • Continue through the recall procedure.
  • Do not delay.

Don't have a recall?

If, after completing this assessment, you decide the issue with the therapeutic good does not warrant a recall:

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