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.

In Step 8: Communication strategy | Sponsor's customer letter | Paid advertisements | Media release

Communication strategy

The purpose of communicating information about a recall is to ensure that product-related injuries are prevented through the identification, removal and/or rectification of unsafe products.

The goal in communicating a product recall is to ensure that those within the supply chain comply with the recall notification.

Cooperation between all entities in the supply chain is essential for the recall action to be effective. You must notify in writing all affected parties within the supply chain.

Include in your communication strategy:

• a description of your intended audience:
  • within Australia
  • in other countries, if you have exported the product
• methods of communication
• a full draft copy of the proposed sponsor's customer letter, advertisements and any other written communications

Match the communication medium to the target audience. Direct your communication to the demographic particular for the recalled product and use an appropriate communication method.

For consumer level recall actions, include how you will manage contact from consumers about the recalled product, including any complaints.

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

Sponsor's customer letter

The sponsor's customer letter is a factual statement of the reasons for the recall action, together with specific details that will allow easy identification of the deficient product.

See Sponsor's customer letter for recalling therapeutic goods for:

• instructions about what to include in the customer letter
• an example letter
• information on addressing customer letters.

In situations where public safety is under immediate threat and distribution of the affected product is limited:

• discuss the information and situation with the TGA
• if the TGA agrees, provide the information to be included in the letter by telephone and email, and then send the sponsor's customer letter to confirm the information.

Heading for customer communication

Use one of the following headings, as appropriate:

• for Class I or Class II recalls:
  • Urgent medicine recall
  • Urgent medical device recall
  • Urgent biologicals recall
  • Urgent product defect correction
  • Implant hazard alert
  • Urgent product defect alert
• for Class III recalls:
  • Medicine recall
  • Medical device recall
  • Biologicals recall
  • Product defect correction.

How to send the customer letter

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

You may use email, mail, facsimile or document delivery systems. The TGA encourages the use of electronic systems, provided the system includes the ability to confirm receipt.

If your recall is Class I or Class II, the letter needs to be labelled as urgent:

• use a subject line for emails that starts with the word 'Urgent' followed by a description of the recall, such as 'Urgent product defect correction' or 'Urgent medicine recall', followed by the name of the deficient product; tag as 'high importance'
• use an envelope for mailed letters with bold red type in the top left corner as described in Sponsor's customer letter for recalling therapeutic goods.

Provide the TGA with a final, signed copy of the sponsor's customer letter at this time.

In some instances, sponsors could consider calling prior to sending the letter, and include this as part of their communications strategy.

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 of time specified in the customer letter. You need to ensure that all affected customers are aware of the recall action, and check that contact details are up-to-date.

Paid advertisements

For consumer level recalls, advertisements paid for by the sponsor are necessary unless complete and accurate distribution lists are available.

Paid advertisements are to:

• be inserted as soon as possible
• be published once in the daily newspapers of each state and territory in which distribution has possibly taken place a few days after the sponsor's customer letter has been sent:
  • as agreed with the TGA

  OR

  • as described by the delegate of the Secretary of the Department of Health in decisions relating to mandatory recalls
• be placed on one of the first ten pages of the newspaper
• have a minimum size of double column width and 10 cm depth and should be enclosed in a diagonally hatched border (see example advertisement).

For advice relevant to consumer recalls, see the ACCC publication Consumer product safety recall guidelines.

Text of advertisements

The title for the advertisements should be the same as the customer letters. The text is to be checked and agreed to by the TGA before publication.

You may need to tailor advertisements for specific groups of consumers. For example, it may be appropriate for the advertisement to be in two languages when the TGA knows that the products were sold to those from a specific non-English speaking background.

The text should contain the following information (see example advertisement):

• name of product
• Australian Register of Therapeutic Goods (ARTG) number (AUST L or AUST R) where this appears on the label of the product
• pack size
• dosage form or model
• batch, lot or serial number
• expiry date (where this appears on the label of the product)
• other details necessary to allow absolute identification
• reason for recall
• potential risks due to the deficiency
• a statement on the continued use or supply of the product, including any alternative products 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
  • provision of replacement stock in the event you are unable to make an acceptable correction
  • availability of unaffected or alternate stock
• a contact telephone number (preferably toll free).

Media release

For Class I and Class II consumer level recalls, it may be necessary for you to issue a media release.

Develop and submit the text of a proposed media release. The TGA may need to seek expert advice in certain situations.

The media release should:

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