What to do if your medicine or medical device is recalled
Find out how you should handle recalls and other market actions.
Like all goods available in Australia, therapeutic goods can sometimes experience problems. This could be an unexpected health issue, a manufacturing or packaging defect or another problem.
When this happens, we decide if a ‘market action’ is needed. A market action aims to correct the problem. Most market actions don’t require the public to take any action.
What do I need to do if my medicine or medical device is recalled?
Recall - return or dispose of a product.
Product alert - be aware of concerns with a product.
Production correction - get repairs or changes to a product.
Quarantine - avoid use of the product.
Market actions can take place for prescription medicines, vaccines, medical devices, blood and tissue products and complementary medicines like vitamin and herbal supplements. The market action chosen depends on the type of product, and how the problem may potentially affect the users’ health and safety.
In cases where you need to act, you may need to stop using the product and it may need to be disposed of or returned to the place of purchase. In other situations, it is safe to continue use, but you and your healthcare professional need to be aware of the problem.
Types of market actions
There are four types of market actions you should be aware of a:
Recall – you need to return or dispose of the product.
For example: certain batches of a vitamin have the wrong tablet in the bottles.
- Product Alert – you need to be aware of a problem or a concern with the use of a product.
For example: some models of an implantable medical device are experiencing reduced battery performance. Patients with the device implanted need to consult with their treating clinician and also be aware of any changes in their symptoms. Product Correction – there is a problem with the product that needs to be corrected or fixed.
For example:- mobile phone app that tracks glucose levels is losing signal and not sending high or low glucose alarms to its users. The app needs to be updated to correct the problem; OR
- certain models of a foldable wheelchair are collapsing while in use by a patient. Stronger bolts will be installed to prevent the problem continuing.
Product Corrections can also include updates to software, instruction manuals, packaging or labelling, as well as fixing the product itself.
A Quarantine – this means you should avoid using the product altogether, until told otherwise.
For example: some saline products used in hospitals have been found to have bacterial contamination. All saline products produced in the same factory are being quarantined while an investigation takes place.
How to stay updated about market actions
When a problem poses a risk to the health and safety of the community, the company that makes or supplies the product (known as a sponsor) is responsible for contacting people about the problem. In some instances, you may receive a letter from the sponsor or be contacted by email or phone.
We will also help spread awareness of the problem for significant actions, or when the end users cannot be traced, by publishing a statement on our website and social media channels. These statements may also appear on the news or on other websites.
You can see our latest statements for significant market actions or search our Database of Recalls, Product Alerts and Product Corrections (DRAC) for all published market actions.
You can also contact the sponsor directly using the contact details included in the information we publish.
Translated resources
Key information about the four types of market actions is available in 5 languages: