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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.
| 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. Includes all necessary information such as affected catalogue / model and / or batch / serial numbers. |
| Type of product | Medicine (including vaccines), medical device or biological. Medicine - Medicines are therapeutic goods (other than biologicals) that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human Medical Device - Medical devices include a wide range of products, such as medical gloves, bandages, syringes, blood pressure monitors and X-ray equipment. They generally have a physical or mechanical effect on the body, or are used to measure (or monitor) the body and its functions. Biological - A good that comprises, contains, or is derived from human cells or tissues; or comprises or contains live animal cells, tissues or organs; and is represented in any way to be, or is likely to be, for therapeutic use. |
| Recall action** | 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 four distinct recall actions - recall, product defect correction, hazard alert and product defect alert.
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| 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.
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| Recall action level | The level to which recall action is to be undertaken. This is 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.
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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.
| Row heading | Definition |
|---|---|
| Type of product | Medicine (including vaccines), 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 levels are given below and are cumulative, e.g. Retail Level, includes Hospital and Wholesale:
|
| 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.
|
| 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** | 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 four distinct recall actions - recall, product defect correction, hazard alert and product defect alert.
|
| Recall action instructions | Information on what customers with affected goods should do. |
| Contact information | Who the customer should contact for additional information and clarification regarding the recall action. |
** These definitions are applicable to the current version of the Uniform recall procedure for therapeutic goods (URPTG).