Database of Recalls, Product Alerts and Product Corrections (DRAC)

A market 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 or use. The different types of market actions are described in the Procedure for Recalls, Product Alerts and Product Corrections (PRAC).

Market actions are published on the DRAC two business days after the TGA sends the agreement letter to the Responsible Entity (the person who is responsible for taking the market action).

This allows time for the Responsible Entity to distribute their communications to the market.

In certain circumstances web statements are also published on the alerts page.

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About the release of this information

The information contained in the DRAC is released under s 61(5C) of the Therapeutic Goods Act 1989.

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 information contained in the DRAC.

Copyright restrictions apply to the DRAC.