The Therapeutic Goods Administration (TGA), part of the Department of Health and Ageing, was established in 1989 as the main Australian Government entity responsible for ensuring that medicines and medical devices used by Australian consumers are evaluated and regulated before they reach the market and monitored as per The Therapeutic Goods ACT 1989. A product recall is the removal of a therapeutic good from supply on the Australian market for reasons relating to their quality, efficacy or safety. Recalls vary in the risk they pose to safety. A recall can occur because of simple problems, such as labeling or packaging errors, or for more serious problems such as an increase in unexpected side effects.
