For recalls and non-recall actions, undertake one of the following:
Submit an online recall or non-recall notification through the TGA Business Services portal. Sponsors, agents and manufacturers should provide all information previously collected within the relevant tabs of the online form.
You may need to submit your recall information via a non-government notification service. For therapeutic goods supplied in at least one Australian state, sponsors, agents and manufacturers are required (by that state) to use GS1 Australia's Recall Health online portal. This is not a TGA requirement.
In these cases, once you have submitted your recall notification via this portal, you do NOT need to also submit it online via the TGA Business Services portal. We will receive your notification automatically and will contact you soon thereafter as we still need to assess the information you have provided.
It is therefore very important that you do NOT proceed to notify customers until you have received an 'Agreement Letter' from the TGA Recalls Section.
Use this reference number in all correspondence about this recall, including follow-up actions.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.