A recall action is taken to resolve a problem with therapeutic goods supplied in the Australian market that have, or may potentially have, deficiencies relating to safety, quality, efficacy (performance) or presentation. Descriptions of the different types of recall actions is available at: About Australian recall actions.
Recall actions are published on the SARA database two business days after the TGA sends the agreement letter to the Responsible Entity (the person who is responsible for taking the recall action).
This allows time for the Responsible Entity to distribute their recall communication.
In certain circumstances (e.g. consumer level recall actions, hazard alerts for implantable products or other noteworthy actions), notices are also published on the alerts page.
Search the System for Australian Recall Actions
About the release of this information
While reasonable care is taken to ensure that the information is an accurate record of recall actions that responsible entities have reported to the TGA or of which the TGA has become aware, the TGA does not guarantee or warrant the accuracy, reliability, completeness or currency of the information or its usefulness in achieving any purpose.
To the fullest extent permitted by law, including but not limited to section 61A of the Therapeutic Goods Act 1989, the TGA will not be liable for any loss, damage, cost or expense incurred in or arising by reason of any person relying on this information.
The information contained in the SARA database is released under s 61(5C) of the Therapeutic Goods Act 1989.
Copyright restrictions apply to the System of Australian Recall actions (SARA).