About recall actions

A recall action is an action taken to resolve a problem with a therapeutic good already supplied in the market for which there are issues or deficiencies in relation to safety, quality, efficacy (performance) or presentation. There are three distinct recall actions - recall, recall for product correction and hazard alert.

  • Recall - The permanent removal of an affected therapeutic good from supply or use in the market.
  • Recall for product correction - Repair, modification, adjustment or re-labelling of a therapeutic good. The corrective action may take place at the user's premises or any other agreed location.
  • Hazard alert - Information issued to healthcare professionals about issues or deficiencies relating to an implanted medical device or biological product and advice about the ongoing management of patients.

Recall actions vary depending on the deficiency of the therapeutic good and the risk the deficiency poses to public safety. A recall action can occur because of simple problems, such as labelling or packaging errors, or for more serious problems such as an increase in unexpected side effects. To assist in the identification of the nature of a recall action, they are classified into one of the following classes based on the potential risk the deficiency poses to patients/consumers:

  • Class I - Recall action occurs when the product deficiency is potentially life-threatening or could cause a serious risk to health.
  • Class II - Recall action occurs when the product deficiency could cause illness, injury or result in mistreatment, but are not Class I.
  • Class III - Recall action occurs when the product deficiency may not pose a significant hazard to health, but action may be initiated for other reasons e.g. quality related issues.

Making a decision to undertake a recall action

A therapeutic goods recall action might be initiated as a result of reports referred from a variety of sources, including:

  • consumers
  • manufacturers
  • wholesalers
  • retail and hospital pharmacists
  • blood and tissue banks
  • pathology departments
  • research facilities
  • medical practitioners and dentists.

The TGA may also request a recall action as a result of:

  • analysis and testing of samples of therapeutic goods
  • advice from an expert advisory committee
  • information received from international regulatory authorities.

Conducting a recall action

The TGA coordinates the recall action, advising the product's sponsor or supplier (responsible entity) of the correct procedures and monitoring the recall action as it is carried out.

Most recall actions are initiated by the person or organisation responsible for the goods when they become aware of a problem. The sponsor has responsibility for the recovery of goods and corrective action.

The level to which a recall action has to be undertaken is based on the significance of the risk and the channels through which the goods have been distributed. The recall levels are:

  • Wholesale - includes wholesalers and state/territory purchasing authorities.
  • Hospital - includes nursing homes and institutions, hospital pharmacists, ambulance services, blood and tissue banks and laboratories as well as wholesale as appropriate.
  • Retail - includes retail pharmacists, medical, dental and other health care professionals as well as wholesale and hospital as appropriate.
  • Consumer - includes patients and consumers, as well as wholesale, hospital and retail levels as appropriate.

Notification of recall actions to stakeholders

Once a recall action has been initiated, the TGA notifies a number of key stakeholders including state and territory health departments. The TGA may also notify other stakeholder groups depending on the type of product being recalled. A list of state and territory health department recall coordinators and other stakeholder groups who may be notified of recalls by the TGA can be found in Appendix IV and V of the Uniform Recall Procedure for Therapeutic Goods (URPTG).

The TGA has a standard operating procedure to alert the Chief Medical Officer (CMO), state and territory Chief Health Officer (CHO) and professional organisations (as appropriate) of certain recall actions.