DRAFT: Uniform Recall Procedure for Therapeutic Goods
Consultation document
Step 2 - Immediate recall actions
Note: This information is part of the Consultation: Revised edition of the Uniform Recall Procedure for Therapeutic Goods
For most issues, the recall action needs to be agreed to by the TGA prior to being undertaken: continue to Step 3.
The TGA recognises that there are instances where immediate action is required that cannot await this agreement. This includes:
Immediate and significant threats
Contact the Australian Recall Coordinator if the issue poses an immediate and significant threat to one of the following:
- consumers
- a company
- employees
- the community as a whole.
Contact the Australian Recall Coordinator if you have:
- An immediate and significant threat
- A crisis involving tampering of therapeutic goods (within 24hrs)
You can call the Recalls Unit 7 days a week, including public holidays.
Follow the advice of the Australian Recall Coordinator and then continue through the steps in the Uniform Recall Procedure for Therapeutic Goods.
Crisis involving tampering of therapeutic goods
You must notify the TGA of actual or potential tampering (section 42T of the Therapeutic Goods Act 1989).
Contact the Australian Recall Coordinator within 24 hours who will then notify the appropriate person.
Note: Civil and criminal penalties apply if you do not notify the TGA.
Related information and guidance
- Crisis Management Guidelines - for the management of actual, potential or threatened tampering of medicines, complementary healthcare products and medical devices
Radiopharmaceuticals
Contact customers immediately if there is an issue with a radiopharmaceutical.
Identify issue
There is an issue with radiopharmaceuticals if:
- the products do not comply with relevant specifications (some have such short half-lives they need to be distributed before all quality control test results are available)
- there are doubts as to the quality, safety, efficacy, performance or presentation.
Inform users
The distributing organisation (usually the manufacturer) needs to take immediate action when there is an issue with radiopharmaceuticals to prevent use by:
- informing customers and users by telephone, email or facsimile
- seeking acknowledgment that unused product has been quarantined.
Contact us
Contact the Australian Recall Coordinator and follow the remaining steps in the Uniform Recall Procedure for Therapeutic Goods.
Your written customer communication
Following the TGA's agreement to the recall action, you must:
- provide the sponsor's customer letter to all known recipients of the affected products.
- send your letter to the head of each relevant department of nuclear medicine and pharmacy (for example, 'Director of Nuclear Medicine' and 'Chief Pharmacist').
Biologicals
Contact customers immediately if there is an issue with a biological.
Identify issue
There is an issue with biologicals if:
- the products do not comply with relevant specifications (some products are distributed before all quality control test results are available)
- there are doubts as to the quality, safety, efficacy or presentation.
Inform customers
Take immediate action to prevent use by:
- informing customers and users by telephone, email or facsimile
- seeking acknowledgment that:
- unused product has been quarantined
- the surgeon has been notified, in case the product has been implanted.
Contact us
Complete the Human blood and tissues recall report form and send it to the TGA.
Contact the Australian Recall Coordinator and follow the remaining steps in the Uniform Recall Procedure for Therapeutic Goods.
Following the TGA's agreement of the recall action, you must provide the sponsor's customer letter to all known recipients of the affected products.