System for Australian Recall Actions (SARA): about the search results

19 December 2013

There are two types of results:

Search result summary

This report shows a list of recall actions listed in a table format ordered from most recent 'Recall action commencement date' to the oldest.

  • All columns except 'Product name/description' can be sorted in ascending or descending order.
  • The product names in the 'Product name/description' column are hyperlinks which can be selected to view the detailed notification about that recall action.
Headings and definitions
Column heading Definition
Recall action commencement date The date the recall action strategy and communication was agreed by the TGA.
Product name/description Brand name/trade name (including active ingredient for medicines), and may include generic reference for the kind of medical devices.
Type of product Medicine, medical device or biological.
Recall action level

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 action classification

Recall actions of therapeutic goods are classified based on the potential risk the deficiency poses to patients/consumers. They are classified as class I, class II or class III.

  • Class I - class I recall action occurs when the product deficiency is potentially life-threatening or could cause a serious risk to health.
  • Class II - class II recall action occurs when the product deficiency could cause illness, injury or result in mistreatment, but are not Class I.
  • Class III - 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 eg. quality related issues.
Recall action level

The level to which recall action has to be undertaken, based on the significance of the risk and the channels through which the goods have been distributed. The recall action levels are wholesale, hospital, retail and consumer.

  • Wholesale - includes wholesalers and state 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

Detail notification

This report shows detailed information about a specific recall action that has been selected from the list. It provides greater detail than that which is viewable in the list of recalls.

Headings and definitions
Row heading Definition
Type of product Medicine, medical device or biological
TGA recall reference Unique number given by the TGA
Product name/description Brand name/trade name (including active ingredient for medicines) and may include generic reference for the kind of medical devices. Includes all necessary information such as affected catalogue/model and/or batch/serial numbers.
Recall action level

The level to which recall action has to be undertaken, based on the significance of the risk and the channels through which the goods have been distributed. The recall action levels are wholesale, hospital, retail and consumer.

  • Wholesale - includes wholesalers and state 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
Recall action classification

Recall actions of therapeutic goods are classified based on the potential risk the deficiency poses to patients/consumers. They are classified as class I, class II or class III.

  • Class I - class I recall action occurs when the product deficiency is potentially life-threatening or could cause a serious risk to health.
  • Class II - class II recall action occurs when the product deficiency could cause illness, injury or result in mistreatment, but are not Class I.
  • Class III - 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 eg. quality related issues.
Recall action commencement date The date the recall action strategy and communication was agreed by the TGA.
Responsible entity Sponsor/supplier/importer responsible for the recall action.
Reason/issue Reason for the recall action
Recall action level

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 action instructions Information on what the customer should do.
Contact information Who the customer should contact for additional information and clarification regarding the recall action.