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Consumer recall notices required for consumer level recalls

Print version

See: URPTG

Uniform recall procedure for therapeutic goods, V2.2

12 December 2019

The sponsor arranges and pays for consumer recall notices which are required for consumer level recalls unless they have complete and accurate distribution lists identifying the end-users. This guide relates to Step 6 of the recall procedure.

You may use the example notice as a template.

Heading for the consumer recall notices

Use one of the following headings, as appropriate:

Class I or Class II recalls

  • Urgent medicine recall
  • Urgent medical device recall
  • Urgent product defect correction
  • Urgent product defect alert

Text for the consumer recall notices

The title of the notices should be the same as the customer letters.

Check and obtain our agreement on the text before publication.

You can tailor notices for specific groups of consumers. For example, it may be appropriate for the notices to be in other language(s) as well as English when the goods were sold to customers from specific non-English speaking backgrounds.

Consider whether to publish notices in social media, taking into account the product under recall and how it is distributed.

Product information

Include:

  • name of the goods
  • ARTG number
  • pack size
  • dosage form or model
  • batch, lot or serial number
  • expiry date (where this appears on the label of the goods)
  • TGA recall reference number
  • other details necessary to allow absolute identification of the goods
  • reason for the recall
  • potential risks due to the issues with the goods
  • advice on the continued use or supply, including any alternative goods available
  • the method of recovery, disposal or specifics of the proposed product correction
  • an estimate of the likely time frame for:
    • the correction to be carried out
    • providing replacement stock if you cannot adequately correct the problem
    • availability of unaffected or alternate stock
  • a contact telephone number (preferably toll free).

Communication strategy

Prepare a communication strategy for your recall action, including draft consumer recall notices, which we will review and agree in consultation with you, or instruct in decisions relating to mandatory recalls.

As a sponsor, you will be able to target your customers more directly if you know who they are and how they are accessing your products. If you are unable to identify who your customers are or where the products you sold are most likely to be located, you will need to distribute your consumer recall notice more widely to ensure a successful recall.

Note: As the sponsor, you are responsible for paying for these notices.

When and where to publish

Having regard to the global multimedia environment including the increasing importance of electronic communications, consideration needs to be given to publishing, broadcasting and distributing the consumer recall notices through a variety of means as appropriate, including but not limited to:

  • daily print media newspapers
  • television and radio
  • online newspapers, magazines, newsletters, trade and professional publications
  • sponsor's own website
  • sponsor media release
  • professional medical colleges and societies
  • social media networks, e.g. Twitter, Facebook, etc.
  • community forums and focus groups
  • Australian Government Primary Health Networks (PHNs)
  • peak consumer groups, e.g. Consumers' Health Forum, Australian Consumers' Association
  • patients enrolled in sponsor developed Patient Support Programs
  • health professionals and their patients enrolled in sponsor initiated Product Familiarisation Programs
  • patient support groups / health consumer organisations
  • industry forums and focus groups.

To ensure consistency and familiarity in raising awareness of consumer level recall actions, your consumer recall notice should be formatted in the same manner as the example notice), wherever practicable to do so.

You should arrange for publication or broadcast of your notice in all forms of media agreed, within three to four business days after sending the customer letter as agreed with us, or as instructed in decisions relating to mandatory recalls.

Where the agreed communication strategy includes publication of your notice in print media daily newspapers, you should ensure the notice will be published:

  • Once, in the daily print media newspapers (of each state and territory where the goods were possibly distributed); and
  • Preferably in one of the first ten pages of the newspaper; and
  • With a minimum size of double column width and 10 cm depth enclosed in a diagonally hatched border (refer to the example notice).

Example consumer notification

We also provide a template for the notice.

picture of an example of a consumer level print media advertisement
Version history: Consumer recall notices required for consumer level recalls
Version Description of change Author Effective date
V2.0 Publication follows a public consultation on a revised edition of the Uniform Recall Procedure for Therapeutic Goods

Recalls and Case Management Section

Regulatory Guidance Team

Publication date: 3 October 2017

Implementation date: 15 January 2018

V2.1 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