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Sponsor's customer letter for recalls

Print version

See: URPTG

Uniform recall procedure for therapeutic goods, V2.2

12 December 2019

The sponsor's customer letter is part of the recall procedure and is a factual statement of the reasons for the recall, together with specific details to identify affected goods easily.

Preparing the customer letter

When preparing the customer letter:

  • Use Australian spelling
  • Use company letterhead
  • Include:
    • the date
    • the name and title of the signatory
    • the TGA recall reference number
    • a statement that the recall is being conducted following consultation with the TGA

You may use the Example of a sponsor's customer letter as a template.

Do not use the sponsor's customer letter to:

  • downplay the seriousness of the issue
  • promote the company or other goods
  • promote or encourage marketing of other goods

Do not:

  • send this letter until we agree to the content: Step 8 of the recall procedure
  • imply that the actions described in the letter proposed to be carried out by the recipient are at the recipient's discretion.
  • use the words 'voluntary' or 'voluntarily' as this may cause confusion regarding the user's requirement to perform the required actions.

Headings

For Class I or II recalls

Choose the appropriate heading from the following:

  • Urgent Medicine Recall
  • Urgent Medical Device Recall
  • Urgent Biologicals Recall
  • Urgent Product Defect Correction
  • Implant Hazard Alert
  • Urgent Product Defect Alert

Emails: start the subject line with 'Urgent' followed by a description of the recall and tag as 'high importance'. For example:

'Urgent product defect correction' or 'Urgent medicine recall', followed by the name of the deficient goods

Mailed letters: Label the letter urgent and label the envelope with Urgent in bold red type in the top left corner.

For Class III recalls

Choose the appropriate heading from the following:

  • Medicine Recall
  • Medical Device Recall
  • Biologicals Recall
  • Product Defect Correction
  • Product Defect Alert

Addressing the letter

How you address the sponsor's customer letter is very important to make sure the most appropriate people in the supply chain receive it.

TGA may request you to provide the letter to specific groups affected by the goods.

Ask the Australian Recall Coordinator if you need help with the best way to address the letters.

Medicines

Address a sponsor's customer letter to: 'Chief Pharmacist'.

Clinical investigational medicine

Send the customer letter to each institution involved in the clinical trial and address to both 'Clinical Investigator' and 'Chief Pharmacist' (send a copy of the letter to each).

Radiopharmaceuticals

Send your letter to the head of each relevant hospital department of nuclear medicine and pharmacy, for example, 'Director of Nuclear Medicine' and 'Director of Pharmacy'.

Medical devices

Address the customer letter intended for hospitals to:

  • 'Chief Executive Officer' - marked to the attention of the head of the appropriate department
  • 'Chief Biomedical Engineer' (if appropriate)
  • 'Director of Nursing Units'
  • any other areas within the hospital and or distribution chain
  • Surgeons (in the case of hazard alerts)
Medical device in a clinical trial

Send the customer letter to each institution using the medical device and address it to 'Clinical Investigator'.

Biologicals

Address the customer letter intended for hospitals to:

  • 'Senior Scientist and/or Pathologist'
  • The recipients' surgeons, if the details are available.

Describing the goods

Describe the therapeutic good in sufficient detail to enable unambiguous identification.

Medicine description

When describing a recall for a medicine, include:

  • the brand name
  • AUST L or AUST R number
  • batch and/or lot number
  • dosage form
  • strength
  • pack size
  • the supplier internal product code if applicable
  • a representative picture or diagram.

Sponsors who wish to provide additional product identifiers in their recall communications are welcome to do so.

Medical devices description

When describing a recall for a medical device, include:

  • the name of the device
  • any other name to identify the goods
  • make and model
  • production identification/manufacturing details - (batch, lot, serial number)
  • additional identifiers - (model number, catalogue number, part number,)
  • ARTG number
  • any distinguishing features
  • a representative picture or diagram
  • the setting in which the device would be used (for example, general surgery)
  • for software, the revision number or number range.

Sponsors who wish to provide additional product identifiers in their recall communications are welcome to do so.

Biologicals

When describing a recall of a biological, include:

  • the name of the biological
  • ARTG number
  • batch and/or lot number
  • manufacturer's name
  • any other relevant details to identify the goods.

Issue (reason for the recall)

Provide a clear description of the issue in simple terms.

This description should be easy for the intended recipient to understand.

Describe clearly:

  • the circumstances the user would be exposed to the maximum potential hazard and associated risk that could result from the reasonably foreseeable use or misuse of the goods
  • the health risk associated with the issue, including details of consequences for the patient and health professional using the affected goods
  • how to mitigate the risk temporarily
  • how this risk or issue will be mitigated or corrected permanently.

Do not:

  • make any comments or provide any descriptions that downplay the level of risk.
  • use any advertorial statements.

Statements of non-compliance

If the goods breach a safety standard that is in force for the type of goods, explain how the goods fail to comply with that standard.

If the goods (if also a consumer good) breach an interim ban or permanent ban by the ACCC, include a statement to that effect.

Action

State clearly what to do and the steps to take to deal with the problem:

  • Emphasise if it is necessary to isolate and quarantine the goods to prevent further use.
  • Include advice in a hazard alert about the ongoing management of patients implanted with the affected medical device or biological.
  • Provide a review of previously generated patient results for in vitro diagnostic medical devices.
  • Request the recall acknowledgement form be returned immediately or by a particular date.
  • Describe the procedure to follow when returning the goods (where applicable).
  • Inform customers that for medical devices, there will be on-site collection and/or replacement or modification, if this is the case.
  • Include specific instructions for packaging biologicals and radiopharmaceuticals before either returning them to the sponsor or disposing of the materials, whichever is relevant.
  • Instruct the customer to inform relevant staff.
  • Request contact details of any organisation supplied with the goods, or instruct them to provide these organisations with a copy of the sponsor's customer letter (with a timeframe).
  • Include instructions to display prominently the recall letter for their staff and customers for a period of either 1 month (where applicable, such as when stock is in transit) or until such time that, the goods are recalled or corrected permanently.

Alternative stock

Where applicable, include advice on:

  • issuing alternative goods
  • credit for goods returned.

Contact details

Explain who to contact to:

  • receive further information
  • receive a refund
  • arrange for the repair or replacement of the goods.

Include business and after hours numbers (preferably toll free numbers) as well as email and website addresses.

Optional information

You may also include additional information, such as:

  • A picture or drawing of the goods (where possible), especially for consumer level recalls; this assists greatly in identifying the affected goods.
  • When further supplies are likely to be available.
  • Instructions about returning the goods.
  • Guidance on clinical management of patients (if appropriate).
  • Advice about whether the goods will be discontinued (if appropriate).

Labelling the envelope

If you are sending letters by mail for safety-related recalls, use a standard envelope with bold red writing in the top left corner.

The printed bold red type, at least one centimetre high, should say one of the following:

  • Urgent Medicine Recall
  • Urgent Medical Device Recall
  • Urgent Biologicals Recall
  • Urgent Product Defect Correction
  • Implant Hazard Alert
  • Urgent Product Defect Alert

Underline these words with three red bars of increasing thickness.

For example: Envelopes for safety-related recalls

Sending customer letters

Send your customer letter to all intended recipients within two working days of agreement by the Australian Recall Coordinator in Step 8.

  • Do not send this letter until we agree to the content in Step 8.
  • The letter may change depending on our independent and objective assessment of your proposal.

You may use email, mail, facsimile, document delivery systems or appropriate technologies including portals with workflow management and audit capabilities. Make sure you can:

  • Confirm receipt as it reduces the need to follow up with customers to confirm they have received the notice.
  • Comply with all the requirements of this procedure.

Send us a final, signed copy of the sponsor's customer letter in Step 9 of the recall procedure.

Confirm receipt of the sponsor's customer letter

Follow up any recipients of the sponsor's customer letter who do not respond within the period specified in the customer letter.

Ensure that all affected customers are aware of the recall.

Check that contact details are up-to-date.

Customer acknowledgement form

A customer's acknowledgement of the recall letter can be an email, facsimile reply form or an acknowledgement or inventory of affected stock on-hand form. You may use the Example customer acknowledgement form as a template.

In your acknowledgement form, make it as easy as possible for your customer to complete the form quickly. Do this by including:

  • the name, pack size, batch number(s) and presentation of the goods
  • a place to record nil stock held or the quantity of full packs or units being returned
  • a place to record the quantity of part-packs being returned, if this is applicable
  • a place to record the name of the organisation, and the name, designation and signature of the person acknowledging the recall
  • a place to record the date of completion of the form.

Ask customers to return the form promptly even if they do not have stock. This can be the acknowledgement of receipt of the recall letter.

Provide a means for customers to return the form free of charge e.g. an email address or free facsimile number(s).

Example of a sponsor's customer letter

We also provide a template for the sponsor's customer letter.

[Company's letterhead]

[Date]

[Name and title of the recipient]

[Address]

[Heading (e.g. URGENT MEDICINE/MEDICAL DEVICE RECALL/IMPLANT HAZARD ALERT)]

TGA Recall Reference Number: [Number]
[Product name: brand/name, model]

[Description of items: ARTG, lot, batch, serial and catalogue numbers; product codes; versions; dates of manufacture; and expiry dates, as applicable]

[Company Name], following consultation with the Therapeutic Goods Administration (TGA), is conducting an [type of recall] of the above [product name and form/description]. We are contacting you as the potentially affected product [has been/may have been] supplied to your organisation.

[Problem/ /Issue]

[Describe the circumstances under which the user would be exposed to the potential hazard and associated risk that could result from the reasonably foreseeable use or misuse of the product.]

The health risk associated with this issue is [details of consequences for the patient and health professional using the affected goods; include the worst-case scenario].

[Describe how to mitigate the risk temporarily and how this risk or issue will be mitigated or corrected permanently.]

[Statement of non-compliance, if applicable.]

This recall does not affect any other [batches/lots/versions] of [product name and form/description] or any other [company name] products [as applicable]. This [batch/lot/version] has been distributed to [hospitals/pharmacy/dentists, etc.] since [date].

[Other product identification details.]

Action

Inspect your stock [immediately (for Class I and II) and quarantine affected stock <batch numbers> on hand to prevent further use].

[For a hazard alert, provide advice about the ongoing management of patients implanted with the affected medical device or biological.]

Complete the attached acknowledgement form [immediately (for Class I and II) or by a specific date for Class III] even if you do not have any affected stock and return it to [email address; fax number (preferably free fax) or other document delivery system] to reconcile this process.

Return affected stock on hand to the address below with the completed inventory form [or provide details for stock return]. [If applicable]

[Address for return of affected stock]

Ensure relevant staff members are informed of this recall, including [locums, inwards goods staff, credit returns staff, biomedical engineers, relevant clinicians who may decide to monitor for adverse events, as applicable].

If you have supplied or transferred any potentially affected product to another facility or organisation, let that facility know of the recall [immediately (for Class I and II)] by providing a copy of this letter.

Place this letter in a prominent position for at least one month.

Replacement stock [if applicable]

The replacement stock to [product name and form/description] is [details of alternate product], which is [currently available for order/being shipped]. The product code is [product code]. Please contact [details] to arrange for replacement.

OR No alternative stock is available currently. Alternative stock is expected to be available from [company] on [date] and will be [available for order/shipped to you].

For further information please call [contact number and, if applicable, contact name].

Thank you for your assistance in helping us to manage this recall.

[OR

[Company name] Pty Ltd sincerely regrets any inconvenience caused to your organisation.]

(signature)

[Name of the company staff responsible for the recall]

[Position]

Alternate sponsor's customer letter – tabulated format

The below format is useful when communicating complicated actions as it condenses down the key points and key actions into a tabulated instructional communication. This format is intended to execute complicated recall actions as efficiently as possible.

URGENT MEDICAL DEVICE RECALL or
PRODUCT DEFECT CORRECTION

Product Name

ARTG:

Sponsor Ref: (if applicable)

TGA Ref:

Date: XX Month 20XX

Dear [recipient],

Following consultation with the Therapeutic Goods Administration (TGA), [Company] is undertaking a [action type] of the above product. We are contacting you as our records indicate the potentially affected product [has been/ may have been] supplied to your organisation.

ISSUE
  • Issue identified with product
HAZARD
  • Hazards that may arise from use of potentially affected goods
CORRECTIVE ACTION BEING TAKEN
  • Action undertaken by sponsor/manufacturer to rectify issue
INSTRUCTIONS FOR USERS
  • Actions for customers both interim and long term if applicable
  • Include instructions for customer response form
CONTACT INFORMATION

For questions regarding this letter, please contact:

Australian Contact Person

This action has been undertaken following consultation with the Therapeutic Goods Administration (TGA).

We apologise for any inconvenience caused to your organisation.

Kind Regards,

Example customer acknowledgement form

We also provide a template for the customer acknowledgement form.

Customer Acknowledgement Form

Please complete this form even if you do not have any affected stock.

[Heading (e.g. URGENT MEDICAL DEVICE RECALL/IMPLANT HAZARD ALERT)]

TGA Reference: RC-20...

[ARTG Number]

[Product Name: brand/name, model]

[Description of items: ARTG, lot, batch, serial and catalogue numbers; product codes; versions; dates of manufacture; and expiry dates, as applicable]

On behalf of this organisation I acknowledge receipt of the [Heading] notice date [insert date of notice] relating to the above product.

FROM:

Organisation
Position
Name
Email or fax no.
Telephone no.
Date
Signature

Affected Stock [Recall and Product Defect Correction only]

If you have no affected stock, tick this box:

If you have affected stock, please complete the stock details table below.

Product Batch/Lot/Date Quantity of stock received Quantity of unused stock subject to recall
(currently in quarantine)
Total affected product

Other Relevant Details:

Other organisations

Has your organisation supplied potentially affected product to any other organisation?

No

Yes I/we will forward all the recall information to the suppliers/distributors/customers

OR

Yes (please supply names and contact information of the organisations)

Return completed forms by fax or email to:

Name
Position
Organisation
Address
Email
Subject of email [Heading as noted above] of [Product details and description including batch/lot details]
Fax no.
Telephone no.

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

Recalls and Case Management Section

Regulatory Guidance Team

Publication date: 3 October 2017

Implementation date: 15 January 2018

V2.2 This version of the URPTG includes a second example template for the sponsor's customer letter. Recalls Section December 2019