Recall procedure

Uniform recall procedure for therapeutic goods, V2.2

12 December 2019

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.

Step 1. Immediate recalls

Uniform recall procedure for therapeutic goods, V2.2

In circumstances where a sponsor becomes aware of a serious risk associated with a therapeutic good, immediate action may be required to protect the health and safety of consumers, a company, employees or the community as a whole.

Such circumstances may include:

For all other recalls and non-recall actions go to Step 2 Obtaining distribution details and stock.

Immediate and significant threats and tampering

Contact the Australian Recall Coordinator if either:

  • The issue with the goods poses an immediate and significant threat to consumers, a company, employees or the community as a whole.
  • There is a crisis involving tampering of therapeutic goods (within 24hrs).

Tampering of therapeutic goods

Any person who supplies, manufactures or sponsors therapeutic goods must notify TGA of actual or potential tampering (section 42T of the Act):

  • Address your notification to the Principal Medical Adviser, c/- the Australian Recall Coordinator
  • Email the notification to recalls@health.gov.au.

Civil and criminal penalties apply if you do not notify TGA.

Tampering occurs when both:

  • The goods are interfered with in a way that affects, or could affect, their quality, safety or efficacy.
  • The interference has the potential to cause, or is done for the purpose of causing, injury or harm to any person.

Crisis management guidelines

The Crisis Management Guidelines for the management of actual, potential or threatened tampering of medicines, complementary healthcare products and medical devices include the crisis management structure, your communications and recall strategy.

These guidelines were developed by the Australian Self Medication Industry (ASMI) in consultation with:

  • Medicines Australia (MA)
  • Complementary Medicines Australia (CMA)
  • the Medical Technology Association of Australia (MTAA)
  • Consumers Health Forum
  • Therapeutic Goods Administration
  • State and Territory health departments
  • Australian Federal Police
  • State and Territory police departments.

We urge you to implement the Crisis Management Guidelines as quickly as possible and ensure that appropriate personnel are trained in their operation.

To obtain a copy of the Crisis Management Guidelines:

  • For sponsors who are members of the following industry associations - ASMI, MA, CMA, MTAA and the Generic and Biosimilar Medicines Association (GBMA) - refer to the 'members-only' page(s) of your association's website.
  • For sponsors who are not members of any of the above industry associations, ASMI or the Australian Recall Coordinator can provide a copy.

Supplementary material is also available: Product contamination & extortion - a protocol for the therapeutic goods industry.

Radiopharmaceuticals

Contact customers immediately by telephone, email or facsimile to prevent use if:

  • the goods do not comply with relevant specifications (some have such short half-lives that they need to be distributed before all quality control test results are available)
  • there are doubts as to the quality, safety, efficacy or presentation of the goods.

Seek customers' acknowledgment that they have quarantined unused goods.

Contact the Australian Recall Coordinator and follow the remaining steps in this procedure.

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 hospital department of nuclear medicine and pharmacy (for example, 'Director of Nuclear Medicine' and 'Chief Pharmacist').

Biologicals, human blood and blood components

There is an issue with biologicals or human blood and blood components if either:

  • The goods do not comply with relevant specifications.
  • There are doubts as to the quality, safety, efficacy or presentation of the goods.

Inform customers

For biologicals: contact customers immediately by telephone, email or facsimile to prevent use.

For blood and blood components: contact the Australian Recall Coordinator by telephone to obtain a TGA recalls reference number before contacting customers.

Seek customers' acknowledgment that they have:

  • quarantined unused goods
  • notified the surgeon (for implanted biologicals)
  • notified the clinician for infused blood components based on assessment by the Blood Service.

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, provide the sponsor's customer letter to all known recipients of the affected products.

Phone the Australian Recall Coordinator

1800 020 653 (free call in Australia)

02 6289 4613 (normal business hours)

0412 205 568 (after hours - available 24/7 for genuine emergencies, including public holidays)

For more details go to the contact information on the TGA website.

Step 2. Obtaining distribution and stock status

Uniform recall procedure for therapeutic goods, V2.2

As the sponsor[2] undertaking a recall or non-recall action, obtain information to:

  • Complete the remaining steps in the recall procedure.
  • Assure us that you have effectively mitigated any risks to public health and safety.

Commercially sensitive or personal information

Identify any commercially sensitive or personal information.

TGA will manage any information that is commercially sensitive or private in nature according to the policy: Treatment of information provided to TGA.

Do not tell us the names of individual patients for privacy reasons.

Information to collect

Collect the following:

  • Do not delay if you are missing some of the details.
  • Continue through the procedure and when you submit your report to us, tell us what is missing and a timeframe for obtaining the information.

Details of the notifier

We need to be able to contact you. Provide the name, phone number and email address of the person that the sponsor has made responsible for the recall.

Describe the issue

Provide all relevant details about the issue and type of therapeutic good including:

  • date issue first detected
  • photographs that help illustrate the issue (e.g. a broken medical device)
  • how the issue occurred
  • history of the incident, with specific dates and times when it occurred or was observed including any reported patient injuries (if applicable).
  • failure rate[3]
  • potential failure mode[4] due to the issue
  • known issues or similar problems that have occurred in the past.

Therapeutic goods report

Give us all the relevant information you have available about the therapeutic goods including:

A description of the therapeutic goods

For medicines also include:

  • dosage form
  • strength
  • pack size.

For medical devices also include a unique identifier such as:

  • catalogue number
  • model reference
  • part number
  • version number.

Manufacturing details including (where applicable):

  • lot number
  • batch number
  • serial number
  • expiry date
  • manufacturing dates
  • donation number or tissue bank number.
Distribution details and stock status of affected goods

Include (where applicable)

  • date released
  • quantity of the batch released
  • dates and quantity distributed to the Australian market
  • where the therapeutic good is in the distribution chain
  • current undistributed stockholding
  • quantity supplied to customers
  • whether the goods have been exported from Australia and, if so, to which countries.

Do not tell us the names of individual patients for privacy reasons.

International regulatory action

For the issue you are notifying, provide the details of any regulatory action taken by other regulators, such as the European Medicines Agency (EMA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), and the US Food and Drug Administration (FDA) for any therapeutic goods imported or supplied within the Australian market.

Sample testing

Where applicable, provide results of tests and other investigations on suspect or other samples.

Surgeon details for implanted therapeutic goods

For implanted therapeutic goods, provide the TGA with the contact details of the relevant surgeons and/or doctors involved.

The TGA collects these contact details so that in the event of an emergency, we can directly contact the relevant parties. This collection is authorised under Australian Privacy Principle 3.6(b), Schedule 1 of the Privacy Act 1988. For general information about privacy, go to Privacy.

Outside of an emergency, affected surgeons and/or doctors will always be contacted by the relevant Australian sponsor.

Extra information

We may seek additional information after the initial review. Examples include:

  • A review of all associated batch manufacturing, packaging, testing, release and distribution records for anomalies that may explain the suspected defect.
  • The examination and retesting of retained samples, if appropriate.

Go to Step 3 Conducting a risk analysis.

For immediate recalls go to Step 9 Implementing the communication and recall strategies.


Footnotes

Step 3. Conducting a risk analysis

Uniform recall procedure for therapeutic goods, V2.2

As the sponsor, analyse the risks associated with the affected therapeutic good(s). You will need this in Step 4 to help you determine the type of recall or non-recall.

Immediate recalls: go to Step 9.

Medical device risk analysis

We review the medical device risk analysis report (often known as a health hazard evaluation or HHE report) in Step 8.

Manufacturer responsibilities

The manufacturer of medical devices (including in vitro diagnostic (IVD) medical devices) is responsible for implementing an appropriate Quality Management System, and using it to identify any potential risks associated with:

  • an adverse event
  • a medical device failure
  • a complaint.

Risk analysis is part of the risk management process, described in ISO 14971 Medical devices - application of risk management to medical devices.

The risk analysis report includes details of:

  • the defect or deficiency
  • potential failure mode[5]
  • failure rate[6]
  • how the defect was identified
  • any reported patient injuries
  • severity and probability of occurrence
  • stock affected
  • proposed market action by the manufacturer
  • potential root causes and corrective actions (if available).

Sponsors undertaking a recall or non-recall action

As the sponsor, you should receive this risk analysis report when the manufacturer notified you of the device defect.

Make sure you are satisfied with the conclusions and recommendations.

You will be submitting this risk analysis in Step 7.

Go to Step 4 Deciding the type, class and level of recall.

If you do not have the manufacturer's risk analysis

If you do not have the manufacturer's risk analysis, for example, your recall or non-recall action is in response to information you receive from customers (e.g. consumers or health care professionals):

  • Gather as much information as you can to help you determine in Step 4 what action to take.
  • Send the report(s) to the manufacturer and request the risk analysis.

Go to Step 4 Deciding the type, class and level of recall.

Biologicals, human blood and blood components

The manufacturer of biologicals, human blood and blood components must both:

  • investigate adverse events and product complaints
  • implement and maintain a written procedure for product recall.

This is specified in the Code of Good Manufacturing Practice (GMP) for human blood and blood components, human tissues and human cellular therapy products.

Sponsor undertaking the recall or non-recall action

Ensure you are satisfied with the conclusions and recommendations before submitting the risk analysis, and go to Step 4 Deciding the type, class and level of recall.

We will review the manufacturer's investigation report in Step 8.

Human blood and blood components

There are two processes for human blood and blood components:

  • Recalls due to process failure and suspected bacterial contamination due to transfusion reaction with a related component.
  • Other recalls such as those triggered by Single Donor Notifications (e.g. report of a post donation illness). The Blood Service reports these recalls to TGA by providing a compiled list on a monthly basis, broken down into common categories.

Medicine risk analysis

The sponsor (when also the manufacturer) is responsible for analysing the risks with medicines.

If the sponsor is not also the manufacturer, the sponsor may conduct the risk assessment in conjunction with the manufacturer.

In the risk analysis report include details of:

  • Both the potential hazards and the likelihood of these hazards
  • Whether any illness or injury has already occurred from use of the medicine
  • Whether any existing conditions could contribute to a clinical situation that could expose people to a health hazard
  • The hazard to individual groups within the exposed population (such as children, the elderly, consumers having surgery or those who are immunocompromised)
  • The degree of seriousness of the health hazard to which the population will be exposed
  • The consequences (immediate or longer term) of occurrence of the hazard
  • Alternative treatment options, including the hazard associated with providing no treatment where an alternative is not available
  • The potential harm to the user because of the issue
  • The likelihood of the issue occurring
  • Results of tests and other investigations on suspect or other samples
  • The ability of the consumer, caregiver or health professional to discover or identify the issue prior to or during use
  • Whether the medicine is outside the manufacturer's specifications
  • The availability of another medicine or alternative therapeutic good, or the risk associated with not providing treatment if another medicine or alternative therapeutic good is not available.

Incorporate other relevant analysis or clinical investigation into your risk analysis and ensure you are satisfied with the conclusions and recommendations.


Footnotes

Step 4. Deciding the type, class and level of recall

Uniform recall procedure for therapeutic goods, V2.2

Check whether the issue with your therapeutic good(s) requires a recall before you consider a non-recall action.

Check you need to conduct a recall

Using the information gathered in Steps 2 and 3 go to Recalls and non-recall actions and follow the guide. This will assist you to decide the:

  1. type of recall
  2. class of recall
  3. level of recall

Check your role as a sponsor for undertaking a recall.

Ask your TGA Business Services administrator to update your recall contact details.

Need help

Contact us if you need help.

Part of our role is to undertake an independent assessment of the risks and ensure that recalls are conducted when appropriate.

You have a recall?

If after completing this assessment, you think you have a recall:

  • Continue through the recall procedure.
  • Do not delay.

Don't have a recall?

If, after completing this assessment, you decide the issue with the therapeutic good does not warrant a recall:

Step 5. Developing a recall strategy

Uniform recall procedure for therapeutic goods, V2.2

For recalls:

  • Draft a recall strategy, to submit in Step 7 of the recall procedure.

For non-recalls:

Do not implement your recall strategy until we agree, because the class, level or type of recall may change depending on our independent and objective assessment.

It is important that we agree with your recall strategy. We look at the risks posed by the therapeutic goods and discuss the issues with you to determine the scale of the recall.

You may discuss the recall strategy with us while you develop it, or we may liaise with you when you submit your strategy in Step 7.

Objectives of a recall

Your recall strategy needs to assure us you are effectively mitigating the risks with the therapeutic goods by:

  • Stopping the distribution, sale and use of the affected goods as soon as possible.
  • Removing or correcting any goods that are a potential risk to health and safety.
  • Preventing further distribution of unsafe goods.
  • Informing the relevant authorities of the issue.
  • Informing the users of the issue.
  • Analysing the root cause and implementing CAPAs[7] to prevent re-occurrence.

Overview of a recall strategy

Your recall strategy should address:

  • consumer, patient and health professional safety
  • the nature of the issue with the goods
  • the number of complaints (including the number of known injuries or incidents)
  • distribution networks
  • exported goods
  • recovery procedures
  • resources for field corrections and availability of alternative goods
  • the factors that may affect the duration of the recall.

Preparing a recall strategy

Include the following in your recall strategy:

  • The details of the goods involved in the recall
  • The issue, including your assessment of the potential hazard or risk posed by the goods
  • The proposed type, classification and level for the recall as decided in Step 4
  • The number of affected units supplied, relevant dates and their distribution within the supply chain including Pharmaceutical Benefit Scheme (PBS) supply for medicines, if applicable
  • Details of any known injuries or incidents associated with the goods
  • How you will collect and dispose, destroy or rectify the recalled goods according to any relevant Commonwealth, state and territory requirements
  • Strategy for notifying customers of exported goods
  • An expected close-out date
  • Action taken to identify and correct the cause of the hazard, including the outcome of any root cause analysis or the time period in which such analysis will occur
  • Contact details of:
    • the sponsor
    • other entities in the supply chain who supply the goods
    • international recipients of exported goods (if applicable).

Footnotes

Step 6. Drafting a communication strategy

Uniform recall procedure for therapeutic goods, V2.2

Your first contact should be with the TGA, except for biologicals and radiopharmaceuticals.

You do not require a communication strategy if you are recalling human blood and blood components.

Follow this step to prepare your communication strategy for both recalls and non-recall actions.

Recall communication strategies

The purpose of communicating a recall

To prevent injuries by identifying, removing and /or rectifying goods that do not meet specifications.

The goal

Enable those in the supply chain to know about and comply with the recall notice.

Cooperation between everyone in the supply chain is essential for the effectiveness of the recall and for notifying everyone involved.

Do not implement your communication strategy until we agree because it may change depending on our independent and objective review of your proposal.

Contents of a communication strategy

Include:

  • A description of your intended audience within Australia and in other countries, if you have exported the goods.
  • Methods for communicating with those in the supply chain.
  • A draft copy of the sponsor's proposed customer letter, consumer recall notices, etc.

Match the communication medium to the target audience and target the relevant demographic for the recalled goods.

Include how you will manage customer enquiries including any complaints.

The minimum requirement for formal written communication is a sponsor's customer letter sent to all known recipients of the affected therapeutic goods.

Sponsor's customer letter

Go to Sponsor's customer letter for recalling therapeutic goods for guidance about:

  • how to prepare and address the letter
  • what to include
  • when and how to send the letter
  • addressing customer letters
  • an example letter.

When to send the customer letter

Send your customer letter to all intended recipients within two working days of agreement with the Australian Recall Coordinator in Step 9.

  • Do not send this letter until we agree to the content in Step 9.
  • The letter may change depending on our independent and objective assessment.

Consumer recall notices

The sponsor arranges and pays for consumer recall notices required for consumer level recalls unless they have complete and accurate distribution lists identifying all end-users.

Go to Consumer recall notices required for consumer level recalls for guidance on how to prepare your notice including:

  • Headings for notices
  • Text for notices
  • Product information
  • Communication strategy
  • When and where to publish the notices

Media release

It may be necessary to issue a media release for some Class I and Class II consumer level recalls.

Develop the text of a proposed media release, which should:

  • contain sufficient detail to define the affected goods uniquely
  • give a clear explanation of the issue without causing unnecessary alarm
  • describe the potential risks due to the issue with the goods
  • state the appropriate actions to be taken by the consumer
  • provide a phone number (preferably toll-free) for consumers to obtain further information.

Send us the draft media release in Step 7.

We may seek expert advice when we review this in Step 8.

Step 7. Submitting recall information

Uniform recall procedure for therapeutic goods, V2.2

For recalls and non-recall actions, undertake one of the following:

Preferred method:

  • Submit an online recall or non-recall notification through the TGA Business Services portal. Sponsors, agents and manufacturers should provide all information previously collected within the relevant tabs of the online form.
    • Upon saving the web form, you will receive a new TGA reference number.
    • The TGA Recalls Section will not be able to see the notification until it has been 'validated' and 'submitted'.
    • Documents such as Draft Customer Letters, Distribution Lists, Consumer Level Communication Strategies and Health Hazard Evaluation reports can be uploaded under the 'Supporting Information' tab.
  • Alternatively, we will still accept email notification from you until 30 June 2020, sent to recalls@health.gov.au with information you currently have including:
    • distribution details and stock status from Step 2
    • risk analysis from Step 3
    • type, class and level of recall from Step 4
    • recall strategy from Step 5
      • not needed for non-recall actions
    • communication strategy from Step 6
    • media release from Step 6 (if needed).
  • You may need to submit your recall information via a non-government notification service. For therapeutic goods supplied in at least one Australian state, sponsors, agents and manufacturers are required (by that state) to use GS1 Australia's Recall Health online portal. This is not a TGA requirement.
  • In these cases, once you have submitted your recall notification via this portal, you do NOT need to also submit it online via the TGA Business Services portal. We will receive your notification automatically and will contact you soon thereafter as we still need to assess the information you have provided.
  • It is therefore very important that you do NOT proceed to notify customers until you have received an 'Agreement Letter' from the TGA Recalls Section.
  • Complete the Human blood and tissues recall report form for biologicals, human blood and blood components. The Blood Service:
    • requests a TGA recall reference number before completing this form. If using the TGA online form, this number can be obtained during the draft submission phase.
    • submits this form, along with the end user recall notification forms (e.g. hospital notification forms) to the TGA after the end-user has been contacted about quarantining the recalled components.

Contact us if you need help about what to submit.

TGA recall reference number

We will issue a TGA recall reference number.

Use this reference number in all correspondence about this recall, including follow-up actions.

Step 8. TGA's assessment of your proposed recall action

Uniform recall procedure for therapeutic goods, V2.2

We will assess your strategies and work with you to address the issue as quickly as possible.

Analysing risk

We will conduct an independent and objective assessment to verify the strategies are appropriate to mitigate the risks posed by the affected goods.

Assessing the recall strategy

We will liaise with you on the recall and will provide advice and assistance in relation to letters, consumer recall notices and recall strategies.

Option to mandate a recall

We prefer to reach agreement with you on an appropriate recall strategy. However, our role is to protect the public health and safety; if necessary we can mandate a recall.

Reviewing your strategy

When reviewing your recall strategy, we also consider:

  • the proposed timeline
  • availability of alternative goods and for critical goods, the effect on future supply.

If necessary, we will seek expert advice (e.g. clinicians or technical experts) to help analyse the risks, especially when the nature or significance of the hazards involved is unclear.

Before you proceed with a recall, it is important we agree to:

  • The type, class and level of recall
  • Your recall strategy, including close-out dates and strategy for exported goods
  • Your communication strategy
  • The text of all your associated written communications including:
    • sponsor's customer letter
    • paid and/or unpaid consumer recall notices
    • media releases.

Timeframes to respond

Our timeframe is to respond and process a recall within 7 clear[8] working days but we usually achieve this within less time.

We review all notifications upon receipt and triage them on a priority basis.

Agreement letter

Once we agree to your recall and communication strategy, we will send you an agreement letter, which will:

  • Specify the agreed details of the recall
  • Provide guidance if you need to notify the recall to the Australian Competition and Consumer Commission (ACCC)
  • Contain templates for your reports.

Notifying others

We will notify some organisations directly and publish the details on our website.

System for Australian Recall Actions (SARA)

We publish all recalls (except blood component recalls) undertaken in Australia in the publicly searchable database, System for Australian Recall Actions (SARA), on the second working day following agreement to the recall strategy.

Recall, safety alert and quarantine notices

We develop a TGA Recall Notice for all recalls, safety alerts and quarantine actions, which includes the:

  • identity of the goods
  • nature of the issue
  • assessment of user hazard
  • distribution of the goods
  • proposed action.

We routinely advise recipients that a notice may contain commercially sensitive and confidential information, and not to distribute it to third parties.

We send the TGA Recall Notice by email to:

For recalls with wider health implications, we will notify immediately:

  • the Australian Government Chief Medical Officer
  • the appropriate state and territory Chief Health Officers.

We also share details of recalls with overseas regulatory agencies when appropriate.

Publishing TGA alerts

We publish TGA alerts on our website to inform and advise consumers and health professionals. The TGA will liaise with you during the preparation of an alert and will provide you with a copy of the alert before it is published.

In deciding on whether to publish an alert, we consider factors including, but not limited to whether the recall action is a:

  • hazard alert
  • consumer level recall
  • vaccine recall
  • any other recall that may have wider implications for public health and safety.

TGA alerts contain information on the recall action, including sufficient detail to define the product uniquely. We give a clear explanation of the issue without causing unnecessary alarm and state the appropriate actions that should be taken by the consumer and health professional.

After publication, we also forward the link to the relevant professional colleges and other consumer and public health organisations, as appropriate.


Footnotes

Step 9. Implementing the recall

Uniform recall procedure for therapeutic goods, V2.2

For sponsors undertaking a recall:

  • Implement your communication and recall strategies once we have agreed to them.

For non-recall actions:

  • Make sure that we agree that a recall is not required.

Send the sponsor's customer letter

Send your sponsor's customer letter to all known customers within two business days from receiving an 'Agreement Letter' from the TGA Recalls Section.

Then, send us a finalised, signed PDF copy of the customer letter.

Radiopharmaceutical recalls

Send the sponsor's customer letter as a follow-up to your initial contact in Step 1 to:

  • all known recipients
  • the head of each relevant hospital department of nuclear medicine and pharmacy (for example, 'Director of Nuclear Medicine' and 'Chief Pharmacist').

Biologicals

Send the sponsor's customer letter to all recipients as a follow-up to your first contact in Step 1.

Notify the ACCC

Regardless of the agreed action level, report the recall to the ACCC if you are recalling therapeutic goods that are also 'consumer goods'. These are sometimes referred to as 'consumer therapeutic goods'[9].

  • Go to the Submit a recall page on the ACCC website
  • Complete and submit the ACCC online form (preferred method).

Recovering affected goods

Once we agree to the recall strategy:

  • Arrange for the recovery of the goods
  • Establish collection points across the distribution network
  • Notify relevant parties, including those in the supply chain and consumers of the method of recovery of the recalled goods
  • Arrange for the disposal of the returned goods: you may arrange for the returned goods to be held and kept separate until it can be rectified or safely destroyed.

You may use company representatives (medical detailers and sales representatives) to recover goods subject to recall.

Make sure you observe relevant state, territory and Commonwealth legislation in relation to unauthorised possession of stock (for example, medicines of addiction and restricted substances).

In the case of a mandatory recall, the TGA may require you to take specified steps for the recovery of the therapeutic goods.

Customer follow-up

It is important that you follow-up with your customers to ensure they have received and followed the instructions in your customer letter.

The level of follow up will depend on the risk and class of the recall.

We recommend making two or three attempts to contact customers, if they do not respond to the customer letter.

Undertake root cause analysis

Undertake a root cause analysis of the issues (usually done by the manufacturer) in parallel with the recall process.

We will review the root cause analysis in the final progress report (Step 11).

This analysis will assist us to assess the ongoing compliance with regulatory requirements under the life-cycle approach described in the regulatory compliance framework.


Footnotes

Step 10. Reporting on the recall

Uniform recall procedure for therapeutic goods, V2.2

Produce progress reports using the templates we provide with your agreement letter.

Your reports should be sufficient for us to analyse the effectiveness of the recall in Step 11.

  • Don't repeat information from a previous report, unless there is a change.

If we are concerned about an aspect of your recall, we will follow this up with you.

Your reports

Include in your reports:

  • the TGA recall reference number (structured as follows: RC-20XX-RN-XXXXX-X)
  • effectiveness of the recall
  • whether the investigation changed the scope of the recall
  • root cause and CAPA taken to prevent recurrence of the problem.

Timeframes for reports

Submit the progress reports by email at:

  • 2 weeks (initial report)
  • 6 weeks (follow-up report)
  • 3 months or at another agreed time (final report).

Provide a single report at 4 weeks for human blood and blood components recalled due to process failure and transfusion transmitted bacterial infection.

The Blood Service provides the TGA with compiled lists monthly and trends quarterly basis for recalls triggered by Single Donor Notifications.

Initial report (2 weeks)

Submit your initial report at the agreed time, usually two weeks after the start of the recall.

Include:

  • Dates when parts of the recall strategy were implemented, e.g. when you sent the sponsor's customer letter.
  • Descriptions of any major impediments, such as the recall or corrective actions not progressing according to agreed timelines.
  • Implications of the initial investigation findings for the scope of the recall, (e.g. whether you or the manufacturer have identified any additional goods with the same issue.)
  • Whether you notified overseas suppliers of exported goods about the recall in Australia.

Follow-up report (6 weeks)

This follow-up report is not needed if the recall is completed within 6 weeks or if we agree it's not needed (e.g. small scale recall.)

Submit your follow-up report at the agreed time, usually six weeks after recall implementation.

Include:

  • Percentage of customers you contacted who have responded to your requested recall:
    • confirming the amount of affected goods held (including none)
    • agreeing to the recall or corrective action
  • Percentage of customers who returned or destroyed their affected goods
  • Identity of customers with goods requiring correction
  • Descriptions of any major impediments, such as the recall or corrective actions not progressing according to agreed timelines.

Final report (3 months or at another agreed time)

Submit your final report at the agreed time, usually three months after implementing the recall.

Include:

  • Percentage of:
    • returned goods
    • returned goods destroyed or disposed. Include a certificate of destruction for destroyed goods.
    • customers with goods that have been corrected, or supplied with the correction
  • Your root cause analysis that led to the recall
  • Proposed CAPA to prevent recurrence of the issue that led to the recall.

Human blood and blood components report (4 weeks)

Recalls of blood and blood components have a 4-week close out.

Complete a final report and include details about the:

  • fate of the components including any patient implications due to the transfusion of the affected components
  • root cause investigation
  • CAPA implemented.

Step 11. Reviewing the recall

Uniform recall procedure for therapeutic goods, V2.2

Components of the review

The TGA examines your progress reports to:

  • verify you have:
    • completed all the agreed actions with documented evidence
    • justified any discrepancies or inconsistencies
    • provided evidence of the fate of the final goods
  • determine whether the following are satisfactory:
    • implementation of the recall
    • the investigation of the issue or hazard that prompted the recall and the root cause identification
    • CAPAs implemented to prevent or minimise recurrence of the issue in the future
  • assess the effectiveness of the recall action
  • assess ongoing compliance with regulatory requirements.

If the TGA is concerned about an aspect of the recall process, we will follow this up with you.

Outcomes of the review

Possible outcomes of our review include:

  1. Actions and information provided is satisfactory:
    • TGA issues a close-out report to you stating that the recall actions were satisfactory and no additional actions are required at this stage.
    • The information submitted will be used to inform manufacturer inspections and for trending purposes in product reviews.
  2. Nature of the root cause or remedial are not apparent:
    • TGA may request additional information, including full CAPA reports for review.
  3. Effectiveness of the recall is not satisfactory:
    • TGA will follow-up with you to determine additional action to ensure the recall is effective.
  4. Identification of a systemic or serious issue (at any stage of the recall process):
    • TGA may schedule an immediate inspection of the manufacturer.
    • TGA may, after further investigation, cancel, suspend, or impose requirements on, the relevant ARTG entries.

Version history

Uniform recall procedure for therapeutic goods, V2.2

Version history: Recall procedure
Version Description of change Author Effective date
V1.0 Publication for consultation Therapeutic Goods Administration 27 October 2015
V2.0 Original publication incorporating feedback from consultation

Recalls and Case Management Section

Regulatory Guidance Team

Publication date: October 2017

Implementation date: 15 January 2018

V2.1 This version of the URPTG includes clarifying amendments in relation to the new (January 2018) requirements for 'quarantine' actions and introduces a more flexible approach for 'consumer recall notices' required as part of conducting consumer level recalls. (These 'notices' were formerly referred to as 'recall advertisements'). Recalls Section February 2019
V2.2

This version of the URPTG includes:

  1. additional clarity on the provision of surgeon contact details for implanted therapeutic goods
  2. amendments related to the online notification of recall and non-recall actions.
Recalls Section December 2019