Important information on the System for Australian Recall Actions
The TGA publishes information about therapeutic goods supplied in the Australian market that have been subject to a recall action in a publicly searchable database.
Recall action means action taken by the responsible entity (being the person who is responsible for taking the recall action) 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.
- Recall actions include: the permanent removal of therapeutic goods from supply in the market, the taking of corrective action in relation to therapeutic goods (such as repair, modification, adjustment or relabelling) and, in the case of medical devices that have been implanted into patients, the issuing of a hazard alert containing information for health practitioners on how to manage patients.
- More information about Australian recall actions is available at: About recall actions
- If you are taking a medicine, using a medical device or have had a medical device implanted into you, that is the subject to a recall action, and you have any concerns you should seek advice from a health professional.
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).
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This Database holds information on recall actions that have been undertaken in Australia since 1 July 2012. Recall actions are included into the SARA two days (excluding weekends) after the decision between the responsible entity and the TGA to commence the recall action. This allows time for the responsible entity to distribute the recall communication. In certain circumstances (e.g. consumer level recall actions and recall actions involving implantable medical devices), notices are published on the alerts page.
Note: If you are taking a medicine, using a medical device or have had a medical device implanted into you, that is the subject to a recall action, and you have any concerns you should seek advice from a heath professional.
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