System for Australian Recall Actions (SARA): questions and answers

It is an online, searchable Database that you can use to find information about recall actions for therapeutic goods that have been co-ordinated by the TGA. It includes recalls, product defect correction, hazard alerts and product defect alerts for a range of therapeutic goods including:

• Prescription medicines
• Over the counter medicines
• Complementary medicines
• Medical devices including in-vitro diagnostic medical devices (IVDs)
• Biologicals

A recall action is undertaken in response to a problem that has been identified with a therapeutic good. Recall actions may also be undertaken for precautionary reasons. By notifying the public about recall actions and in some cases removing potentially deficient products from the market, the exposure of the public to potentially unsafe therapeutic goods is reduced.

A recall action is a market action taken to resolve a problem with a therapeutic good already supplied in the market for which there are established issues or deficiencies in the safety, quality, efficacy, performance or presentation.

The System for Australian Recalls Actions (SARA) was created to provide the public with a searchable database to improve access to information about therapeutic goods that have been subject to a recall action in the Australian market.

The TGA is committed to improving transparency, trust and confidence in the regulatory processes by providing recall information to the public.

When a recall action is being conducted in Australia, the product sponsor/supplier or importer (responsible entity) must notify the TGA. The TGA, like other regulatory agencies around the world, monitors the recall action process to ensure that it is carried out effectively and in a timely manner and that appropriate corrective actions have been put in place to reduce the likelihood of the same issue recurring.

While the sponsor/supplier is responsible for notifying their customers directly of a recall action, the TGA also plays a role in communicating recall actions to the public.

When agreeing to a recall action the TGA ensures that an accurate summary of a recall is captured in the SARA database. Generally, the TGA uses the information in the sponsor's proposed recall communication as well as information gathered by the TGA in their assessment of the recall action including clinical and risk assessments to populate SARA. The TGA may update information recorded in SARA to keep the entries current and accurate.

The TGA uses the information in the database primarily to manage the recall action process. It is also used to identify trends in product deficiencies and manufacturing failures. This data may be used by the TGA to identify product safety issues.

Detailed information about how to use the Database can be found at Instructions for searching the System for Australian Recall Actions. You can search the Database for a product name, trade name (also known as brand name), active ingredient, or generic device description keyword or an ARTG number. Once you have typed in 3-5 characters a list will appear. You can also search for all recall actions within a particular date range, or a combination of a date range and a product name/ARTG number, etc..

• Search result summary - this report will show a list of recall actions that matched the search criteria that was used. From this list, a specific recall action can then be selected.
• Notification detail - this report shows detailed information about a specific recall action that has been selected from the list. It provides greater detail than that which is viewable in the search result summary. See System for Australian Recall Actions: about the search results.

• Export to PDF - the search result summary information can be saved or exported as a PDF document. This document will include the summary information as a table including the Commencement Date, Product Name, Type of Product, Action Type, Classification and Level fields from the search results.
• Export to Excel - the search result information can be saved or exported as an editable MS Excel spreadsheet. This spreadsheet will include all SARA database fields of the recall actions in the search results. This provides greater detail, accessibility, and data analysis potential than the Export to PDF option.

If you have concerns about your health you should contact your general practitioner or other healthcare professional as soon as possible.

To confirm that the product you are currently using is the same as the product in the Database it is important to check the 'Product name /description' field which contains information such as product name, batch/serial numbers etc that will assist you to properly identify the product.

If it is the same product that you are using, you should follow the information contained in the 'Recall instructions' field. The relevant contact details for the recall action can be found in the 'Contact information' field.

For factors to consider when interpreting search results see System for Australian Recall Actions: about the search results.

The product sponsor (responsible entity) is responsible for sending the recall action notice to their customers. In certain circumstances (e.g. consumer level recall actions and recall actions involving implantable medical devices), notices are also published by the TGA on the alerts page.

Information about therapeutic good recall actions occurring overseas is made available online by other agencies. This includes information from the United States Food and Drug Administration (US FDA), Health Canada, the European Medicines Agency (EMA), the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) and others.

Consumers should be aware of the risks of importing therapeutic goods for personal use that are not included in the Australian Register of Therapeutic Goods (ARTG) or do not comply with the Australian regulatory requirements. For more information see Buying medicines and medical devices over the Internet.