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Recall procedure

Uniform recall procedure for therapeutic goods, V2.1

7 February 2019

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We encourage sponsors to follow this procedure to decide, in consultation with us, to take the most appropriate action (recall or non-recall) to mitigate an actual or potential public health risk from a particular good.

However, a TGA delegate of the Secretary of the Australian Government Department of Health (the Secretary) can exercise powers under the Therapeutic Goods Act 1989 (the Act) to mandate the sponsor to recall therapeutic goods to protect public health.

Don't make the mistake of determining the action to take (recall or non-recall) without going through this procedure and obtaining our agreement.

Which steps to follow

Type of recall Steps to follow
Immediate recalls 1 and other steps if required
Other recalls 2 to 11
Non-recall actions 2 to 4; 6 to 11 as applicable
Product tampering 1

Note

This recall procedure does not apply to blood recalls triggered by Single Donor Notifications (e.g. report of a post-donation illness). The Blood Service also provides a compiled list to the TGA on a monthly basis, broken down into common categories.

Recall pathways (flowchart)

Immediate recalls (from Step 1)

Immediate recalls start from Step 1, because it's critical you contact the Australian Recall Coordinator and customers earlier than normal.

The flowchart shows who needs to be contacted (and in what order) for each case. After this initial part of the recall procedure, ensure you follow the remaining steps (Steps 2 to 11).

Step 1

Step 1: Immediate recalls

see text version of flowchart for details
Text version of Step 1 flowchart
Immediate and significant threat
  1. Contact the Australian Recall Coordinator
  2. Implement and report on the agreed recall strategy
Actual (or potential) product tampering
  1. Contact the Australian Recall Coordinator
  2. Implement and report on the agreed recall strategy
Human blood or a blood component
  1. Contact the Australian Recall Coordinator
  2. Get TGA recalls reference number
  3. Contact customers
  4. Implement and report on the agreed recall strategy
Biologicals
  1. Contact customers
  2. Contact the Australian Recall Coordinator
  3. Implement and report on the agreed recall strategy
Radiopharmaceuticals
  1. Contact customers
  2. Contact the Australian Recall Coordinator
  3. Implement and report on the agreed recall strategy

All other recalls (from Step 2)

Determining the action to take

Step 2 Obtaining distribution and stock status
next step
Step 3 Conducting a risk analysis
next step
Step 4

Deciding the type, class, and level of recall

You can contact the TGA for help with deciding if a recall is needed.

For non-recall actions, skip to Step 6 (Drafting a communication strategy).

next step

Recalling the goods

Step 5 Developing a recall strategy
next step
Step 6 Drafting a communication strategy
next step
Step 7 Submitting recall information
next step
Step 8

TGA assessment of your recall

If the TGA and the sponsor cannot reach agreement at this step, the TGA has the option to mandate a recall.

next step
Step 9 Implementing the recall
next step
Step 10

Reporting on the recall

Provide recall progress reports, including root cause assessment, and corrective and preventative actions (CAPA).

next step
Step 11

Reviewing the recall

The TGA will review the progress reports, and decide if any further actions are required.

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