About Australian recall actions

We have released a preview of the new Procedure for Recalls, Product Alerts and Product Corrections (PRAC) which will take effect in early March 2025. Please familiarise yourself with this new resource now.

Sponsors should continue to follow the Uniform Recall Procedure for Therapeutic Goods (URPTG) until we advise the precise date for when the URPTG will be replaced by the PRAC.

What recall actions are

Recall actions are undertaken by following the Uniform Recall Procedure for Therapeutic Goods (URPTG). The aim is to resolve problems identified with the safety, quality, efficacy, performance or presentation of therapeutic goods supplied in the Australian market. 

Undertaking recall actions

Australian sponsors may notify us themselves or be prompted by us to undertake a recall action. 

The process is that the sponsor submits a notification to us, following the requirements detailed in the URPTG. We review, agree and then coordinate the recall action by advising sponsors on the correct procedures to undertake. We monitor progress of the recall action. 

If necessary, we can impose requirements on sponsors to recall therapeutic goods under provisions within the Therapeutic Goods Act 1989.

The sponsor has responsibility for the recovery and disposal of the goods, or completion of the agreed corrective action.

Recall action hazard classifications 

To assist in identifying the most effective recall action strategy, we classify the hazards posed by problems with therapeutic goods into one of the following classes:

• Class I - Most serious safety-related - When there is a reasonable probability that the use of, or exposure to, the deficient therapeutic good(s) will cause serious, permanent or long term adverse health consequences or death.
   
• Class II - Urgent safety-related - When the use of, or exposure to, the deficient therapeutic good(s) may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
   
• Class III - Lowest risk - when the use of, or exposure to, the deficient therapeutic good(s) is not likely to cause adverse health consequences and the identified problem/s are therefore not safety related. 

Full descriptions of each class, including examples, are detailed in the URPTG.

Recall action types

Recall actions may vary depending on the specific deficiency or defect associated with the therapeutic good and the risk it poses to public health and safety. There are four distinct Recall actions detailed in the URPTG:

• Recall - A recall is conducted to remove therapeutic goods permanently from the market or from use when there are deficiencies or potential deficiencies in safety, quality, efficacy, performance or presentation.
   
• Product defect correction - A product defect correction is undertaken to correct a specific or potential deficiency. In some instances, the product can continue to be used if there is robust mitigation in place until a permanent correction has been implemented.
   
• Hazard alert - A hazard alert is issued for an implanted therapeutic good with a deficiency or potential deficiency relating to its safety, quality, performance or efficacy because implanted goods cannot be recalled.
   
• Product defect alert - Discontinuation of treatment is sometimes riskier than continued use of the deficient product. This occurs for critical therapeutic goods for which there is no alternative product or for which a recall action will result in interruption of patient treatment, a medical device supply disruption or a medicine shortage.

Full descriptions of each action are detailed in the URPTG.

Recall action levels 

The level of a recall action is determined by the depth to which the goods have been distributed into the market. The recall levels in descending order of distribution are:

• Wholesale - Includes:
  • medicine and medical device wholesalers, who are third parties holding goods to distribute to retailers or other organisations
  • State and Territory purchasing authorities.
• Hospital - Includes:
  • wholesale level
  • hospitals
  • nursing homes, respite facilities and other healthcare institutions
  • clinical investigators and the institutions in which clinical investigations are performed
  • hospital pharmacies, blood banks, pathology laboratories, operating facilities, fractionators, human tissue banks, other hospital departments
  • ambulance services including the Royal Flying Doctor Service.
• Retail - Includes:
  • hospital and wholesale levels
  • retail pharmacists
  • dentists
  • health care professionals
  • all other retail outlets such as supermarkets, health food stores and online stores.
• Consumer - Includes:
  • retail, hospital and wholesale levels
  • patients and other consumers.

Recall actions are performed on every level, to the depth of supply. In a Retail level recall action, sponsors must notify affected retailers, as well as hospitals and wholesalers on their customer list. 

Notification of recall actions to stakeholders

We may notify stakeholder groups (including the nominated state and territory health department recall coordinators) depending on the type of product being recalled and the affected patient group. 

Our website is regularly updated with the contact details of the various state and territory health department recall coordinators and other stakeholder groups who we may notify about recall actions.