Uniform recall procedure for therapeutic goods (URPTG), 2004 edition

2004 edition

Book pagination

12 April 2017

G. Recall letters, paid advertisements and media releases

Recall letters should include a factual statement of the reasons for the recall of the product, together with specific details that will allow the product to be easily identified

(See example letter at Appendix VIII).

The text of the recall letter is to be sent to the Australian Recall Co-ordinator for approval before being despatched. The letter, which may be sent by mail or facsimile or e-mail (and then also posted if sent by facsimile or e-mail), should be despatched within 48 hours of receiving the Co-ordinator's agreement. A signed copy of the recall letter (or facsimile) to customers is to be sent to the Australian Recall Co-ordinator at this time.

Medicine, medical device and human blood and tissues* recall letters, facsimiles or e-mails

[Use company letterhead; include date and name and title of signatory.]

Headings

If Class III:

'Medicine Recall' or 'Medical Device Recall' or 'Human Blood and Tissues Recall' or 'Recall for Product Correction' or 'Hazard Alert'

If Class I or II:

'Urgent Medicine Recall', or 'Urgent Medical Device Recall' or 'Urgent Human Blood and Tissues Recall ' or 'Urgent Recall for Product Correction' or 'Hazard Alert'

Composition of text

  1. name of the product;
  2. ARTG number (AUST L or AUST R) when this appears on the product;
  3. unique identifying number(s) (Human Blood and Tissue products);
  4. pack size;
  5. dosage form or model;
  6. batch or serial number;
  7. expiry date (when this appears on the product);
  8. other details necessary to allow absolute identification (eg. catalogue/ part/ order number as appropriate);
  9. reason for recall;
  10. necessity to identify and quarantine the product from further sale or supply;
  11. the method of recovery (or disposal, if appropriate) or product correction which will be used;
  12. a request to retain the letter in a prominent position for one month in case stock is in transit (where applicable); and
  13. Contact telephone number and facsimile return numbers (preferably toll free).

If safety to the public is involved and distribution is limited, after discussion with the Australian Recall Co-ordinator, the information listed above may be given by telephone and then confirmed by the recall letter. This should happen in the case of radiopharmaceuticals, for which specific instructions for the packaging and return to the sponsor, or specific instructions for the disposal of the materials, are to be given.

Where recalled stock has been distributed to a limited number of hospitals and the recall letter is not to be sent to all hospitals in the respective State/Territory, the letter is to include the following statement or words to the effect of:

'If any of the recalled stock could have been transferred from your hospital to another, please immediately let that hospital know of the recall. It would be appreciated if you would then telephone - long distance callers reverse charge - the nearest company office indicated below so that we can make contact with the hospital supplied from your hospital.'

A business reply card or a facsimile reply form (see appendix VIII for an example) may be included with the recall letter where the sponsor considers this necessary.

*Recall letters for Human Blood and Tissue products must be sent by facsimile with a follow up phone call to hospitals. Sending letters is optional.

Envelopes for dispatch of recall letters

A distinctive standard envelope is required to ensure that it is easily recognised among the large amount of mail usually received by professional people. The envelope is used for all classifications of recalls.

The envelope has been approved by Australia Post and measures about 220 x 110 millimetres and has a red border 2 - 3 millimetres wide along the top edge of the face.

The words 'Urgent - Medicine Recall' or 'Urgent - Medical Device Recall' or 'Urgent - Human Blood and Tissues Recall' or 'Urgent - Product Correction' or 'Hazard Alert' are printed diagonally in bold red type at least one centimetre high in the top left hand corner and are underlined with three red bars of increasing thickness (See example envelopes at Appendix VII).

Full details of the design of the envelope and advice on commercial sources of supply may be obtained from the Australian Recall Co-ordinator.

Addressing of recall letters and envelopes

  1. Medicine Recalls

    For hospitals, address to:

    'Chief Pharmacist'.

    In the case of a clinical investigational medicine, address to:

    'Clinical Investigator' and 'Chief Pharmacist' (a copy of the letter to each) in the institutions in which the clinical investigations have been performed.

    In the case of radiopharmaceuticals a copy of the letter should be sent to the head of each relevant department of nuclear medicine and pharmacy (e.g. 'Director of Nuclear Medicine').

  2. Medical Device Recalls

    In the case of medical devices in a hospital, address to:

    'Chief Executive Officer'

    and marked to the attention of the head of the appropriate department. In the case of a clinical investigational device, address to:

    'Clinical Investigator'

    and if appropriate:

    'Chief Biomedical Engineer'

    and/or:

    'Director of Nursing'.

  3. Human Blood and Tissues

    'Senior Scientist and/or Pathologist'

    and if appropriate, the Recipient's Surgeon.

If the depth of recall is to consumer or retail level and the consumers or retail outlets cannot be identified (see Section H), advertisements paid by the sponsor are to be inserted in the daily print media of each State/Territory in which distribution has possibly taken place.

Description of paid advertisements

Choice of daily media - This should be made in consultation with the Australian Recall Co-ordinator or as described by the delegate in decisions relating to mandatory recalls. The Australian Recall Co-ordinator has available a list of the major media in each State and Territory. Consideration should also be given to the need to inform ethnic groups.

Size - Double column width by 10cm deep is the minimum size for advertisements, which should be enclosed in a diagonally hatched border.

Position - Advertisements are placed in one of the first five pages of each of the daily print media chosen.

Text - This is submitted to the Australian Recall Co-ordinator for confirmation before it is sent for publication.

Headings

If Class III: 'Medicine Recall' or 'Medical Device Recall' or 'Recall for Product Correction'.

If Class I or II: 'Urgent Medicine Recall' or 'Urgent Medical Device Recall' or 'Urgent Recall for Product Correction'.

Composition of text

  1. name of product;
  2. ARTG number (AUST L or AUST R) where this appears on the label of the product;
  3. pack size;
  4. dosage form or model;
  5. batch or serial number;
  6. expiry date (where this appears on the label of the product);
  7. other details necessary to allow absolute identification;
  8. reason for recall;
  9. a statement on the continued use or supply of the product;
  10. the method of recovery (or disposal, if appropriate) and/or product correction which will be used;
  11. if the hazard to the patient is serious, indications of clinical symptoms and advice to consult a medical practitioner, if desired; and
  12. where the sponsor is unable to make a correction or offer replacement stock within a reasonable period, an indication of the likely time frame for correction or provision of replacement stock; and
  13. Contact telephone number (preferably toll free).

Media release

In the case of Class I or II consumer level recalls, it may be necessary to issue a media release. The text of the media release is developed by the sponsor, in consultation with the Australian Recall Co-ordinator. Expert advice may also be required.

The media release must contain sufficient detail to uniquely define the product, together with a clear outline of the problem (without causing unnecessary alarm) and must state the appropriate response by the consumer. A telephone number of the sponsor, to allow 24-hour access to further information, should be given.

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