What you need to know… Recall notice advertisements

The purpose of this guideline is to provide assistance on how product recall notices should be set out in accordance with regulatory requirements.

RECALL NOTICES FOR THERAPEUTIC GOODS

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

Position – advertisements should be placed where possible in one of the first five pages of each of the daily print media chosen.

Text – the advertisement must be 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).

PRODUCT SAFETY RECALLS AUSTRALIA

The recall notice should not include the words ‘voluntary recall’.  The design of a newspaper recall notice should:

  • be a minimum size of 12 cm x 3 columns;
  • use the red hatched boarder with the red safety triangle in the upper left hand corner – this is an internationally recognised safety symbol;
  • include the headline “Product Safety Recall” in red characters and 16 point font size;
  • use 10 point, Sans serif typeface in the body with bold section headings as above ; and
  • include the words “See www.recalls.gov.au for Australian product recall information” at the base of the notice in bold 14 point font size.

The notice should also include…

PRODUCT DESCRIPTION – a clear description of the product, including the name, make and model and any distinguishing features, batch or serial numbers. Dates the product was available for sale should also be included.

PICTURE OF THE PRODUCT – a photograph or drawing of the product will provide the consumer with a convenient and effective means of identifying the product.

DESCRIPTION OF THE DEFECT – a clear description of what the defect is.  The defect should be described in simple terms so that the average consumer can understand what the problem is.  Suppliers should refrain from using overly technical terminology wherever possible.

A STATEMENT OF THE HAZARD – a description of the maximum potential hazard and associated risk.  Where available, an appropriate hazard symbol should be included.

“CONTACT DETAILS”, which explains who consumers should contact to receive a refund or have the product repaired or replaced.  Business and after-hours telephone numbers should also be included (preferably toll free), as well as email and website addresses.

“WHAT TO DO”, which explains the immediate action the consumer should take.  For example, “Cease use immediately and return the product to the place of purchase for a full refund”.  It should be clear that the consumer should return the product and not dispose of it.  Suppliers should ensure they minimise the inconvenience to consumers in order to encourage consumer compliance with the recall notice.

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