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Recall procedure

Uniform recall procedure for therapeutic goods, V2.2

12 December 2019

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Step 2. Obtaining distribution and stock status

As the sponsor[2] undertaking a recall or non-recall action, obtain information to:

  • Complete the remaining steps in the recall procedure.
  • Assure us that you have effectively mitigated any risks to public health and safety.

Commercially sensitive or personal information

Identify any commercially sensitive or personal information.

TGA will manage any information that is commercially sensitive or private in nature according to the policy: Treatment of information provided to TGA.

Do not tell us the names of individual patients for privacy reasons.

Information to collect

Collect the following:

  • Do not delay if you are missing some of the details.
  • Continue through the procedure and when you submit your report to us, tell us what is missing and a timeframe for obtaining the information.

Details of the notifier

We need to be able to contact you. Provide the name, phone number and email address of the person that the sponsor has made responsible for the recall.

Describe the issue

Provide all relevant details about the issue and type of therapeutic good including:

  • date issue first detected
  • photographs that help illustrate the issue (e.g. a broken medical device)
  • how the issue occurred
  • history of the incident, with specific dates and times when it occurred or was observed including any reported patient injuries (if applicable).
  • failure rate[3]
  • potential failure mode[4] due to the issue
  • known issues or similar problems that have occurred in the past.

Therapeutic goods report

Give us all the relevant information you have available about the therapeutic goods including:

A description of the therapeutic goods

For medicines also include:

  • dosage form
  • strength
  • pack size.

For medical devices also include a unique identifier such as:

  • catalogue number
  • model reference
  • part number
  • version number.

Manufacturing details including (where applicable):

  • lot number
  • batch number
  • serial number
  • expiry date
  • manufacturing dates
  • donation number or tissue bank number.
Distribution details and stock status of affected goods

Include (where applicable)

  • date released
  • quantity of the batch released
  • dates and quantity distributed to the Australian market
  • where the therapeutic good is in the distribution chain
  • current undistributed stockholding
  • quantity supplied to customers
  • whether the goods have been exported from Australia and, if so, to which countries.

Do not tell us the names of individual patients for privacy reasons.

International regulatory action

For the issue you are notifying, provide the details of any regulatory action taken by other regulators, such as the European Medicines Agency (EMA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), and the US Food and Drug Administration (FDA) for any therapeutic goods imported or supplied within the Australian market.

Sample testing

Where applicable, provide results of tests and other investigations on suspect or other samples.

Surgeon details for implanted therapeutic goods

For implanted therapeutic goods, provide the TGA with the contact details of the relevant surgeons and/or doctors involved.

The TGA collects these contact details so that in the event of an emergency, we can directly contact the relevant parties. This collection is authorised under Australian Privacy Principle 3.6(b), Schedule 1 of the Privacy Act 1988. For general information about privacy, go to Privacy.

Outside of an emergency, affected surgeons and/or doctors will always be contacted by the relevant Australian sponsor.

Extra information

We may seek additional information after the initial review. Examples include:

  • A review of all associated batch manufacturing, packaging, testing, release and distribution records for anomalies that may explain the suspected defect.
  • The examination and retesting of retained samples, if appropriate.

Go to Step 3 Conducting a risk analysis.

For immediate recalls go to Step 9 Implementing the communication and recall strategies.


Footnotes

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