What is a medicine recall?

A medicine recall is when a medicine or therapeutic product is withdrawn from being sold; or sold with specific warnings due to concerns with it. It might be because of safety, quality, effectiveness, labelling or packaging of the medicine or product.

It could be because of a problem with the medicine itself, like unexpected side effects, or a problem with something unrelated to the medicine, such as a packaging or labelling mistake.

The Therapeutic Goods Administration (TGA) and pharmaceutical companies can recall medicines. The TGA is the government body responsible for medicine safety, so it can enforce a medicine recall, even if the company does not agree.

The TGA might order the pharmaceutical company to:

• Recall — take the medicine off the market permanently
• Make a correction — such as fix a mistake on a label or instructions for use of a medicine or device
• Alert — inform about a problem with a medicine that people still need to use, and suggest steps to minimise risk (for example, if no alternatives are available or shortages would be more dangerous to patients)

If there is an alert but you need to keep taking the medicine, your doctor or pharmacist can guide you on what to monitor and how to manage side effects.

You can find details of any medicines that have been recalled at the Recall actions database.

Who makes and sells medicines?

Medicines are made by pharmaceutical companies. Many of these companies are based overseas. Often medicines are sold through Australian branches of those companies and sometimes they are distributed through a business in Australia.

Who regulates medicines?

The Australian Government regulates medicines and health products through the Therapeutic Goods Administration, or TGA.

The TGA is responsible for the quality of all medicines with an AUST number on the label, and can recall these medicines if a problem is found. This is true for medicines made in Australia or overseas.

Medicines and medical devices that you buy over the internet that aren’t regulated by the TGA cannot be recalled by the TGA.

What products does the TGA regulate?

The TGA regulates therapeutic goods including:

• prescription medicines
• vaccines
• sunscreens
• vitamins and minerals
• medical devices
• blood and blood products

What should I do if my medicine is recalled?

The first thing to do if you think your medicine or therapeutic product is recalled, is talk to your doctor or pharmacist. They will tell you if the recall relates to your product, as sometimes only a particular dose or batch number is involved in a recall.

They can advise you on if you should keep taking the medicine carefully, stop taking the medicine or take a different medicine.

You should also follow the information in the recall instructions. There will be contact details in this instruction for more information.

FIND A HEALTH SERVICE — The Service Finder can help you find doctors, pharmacies, hospitals and other health services.

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Making a report

If you have worries about a medicine’s packaging or have had a side effect, you can report it online or by phone to the TGA.

If you have taken too much or the wrong medication the Poisons Information Centre is also available 24 hours a day on 13 11 26.

If you have a question about your medicine, you can call the Medicines Line on 1300 MEDICINE (1300 633 424) during NSW business hours and speak to a pharmacist.

Resources and support

To search medicines by active ingredient or brand name, use the healthdirect search feature. It provides useful information about medicines such as their use, whether they are available on the Pharmaceutical Benefits Scheme and product recalls.

You can search for recalled medicines through the System for Australian Recall Actions.