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Recall procedure

Uniform recall procedure for therapeutic goods, V2.2

12 December 2019

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Step 5. Developing a recall strategy

For recalls:

  • Draft a recall strategy, to submit in Step 7 of the recall procedure.

For non-recalls:

Do not implement your recall strategy until we agree, because the class, level or type of recall may change depending on our independent and objective assessment.

It is important that we agree with your recall strategy. We look at the risks posed by the therapeutic goods and discuss the issues with you to determine the scale of the recall.

You may discuss the recall strategy with us while you develop it, or we may liaise with you when you submit your strategy in Step 7.

Objectives of a recall

Your recall strategy needs to assure us you are effectively mitigating the risks with the therapeutic goods by:

  • Stopping the distribution, sale and use of the affected goods as soon as possible.
  • Removing or correcting any goods that are a potential risk to health and safety.
  • Preventing further distribution of unsafe goods.
  • Informing the relevant authorities of the issue.
  • Informing the users of the issue.
  • Analysing the root cause and implementing CAPAs[7] to prevent re-occurrence.

Overview of a recall strategy

Your recall strategy should address:

  • consumer, patient and health professional safety
  • the nature of the issue with the goods
  • the number of complaints (including the number of known injuries or incidents)
  • distribution networks
  • exported goods
  • recovery procedures
  • resources for field corrections and availability of alternative goods
  • the factors that may affect the duration of the recall.

Preparing a recall strategy

Include the following in your recall strategy:

  • The details of the goods involved in the recall
  • The issue, including your assessment of the potential hazard or risk posed by the goods
  • The proposed type, classification and level for the recall as decided in Step 4
  • The number of affected units supplied, relevant dates and their distribution within the supply chain including Pharmaceutical Benefit Scheme (PBS) supply for medicines, if applicable
  • Details of any known injuries or incidents associated with the goods
  • How you will collect and dispose, destroy or rectify the recalled goods according to any relevant Commonwealth, state and territory requirements
  • Strategy for notifying customers of exported goods
  • An expected close-out date
  • Action taken to identify and correct the cause of the hazard, including the outcome of any root cause analysis or the time period in which such analysis will occur
  • Contact details of:
    • the sponsor
    • other entities in the supply chain who supply the goods
    • international recipients of exported goods (if applicable).


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