Uniform recall procedure for therapeutic goods (URPTG), 2004 edition

2004 edition

Book pagination

12 April 2017

E. Information required for assessment of recall

Prior to notification of a recall situation to the Australian Recall Co-ordinator or the State/Territory co-ordinator, the sponsor should gather all the relevant information on problem reports, the product and its distribution, and action proposed. Similarly, the Co-ordinator should make available to the sponsor all relevant information on hand. Some of the information (for example, batch size, distribution chains and quantities distributed) will only be known to the sponsor and it is important for it to be readily accessible for use in recall situations.

The type of information required may include:

  • Details of the problem
    • name, telephone and facsimile number of the person reporting the problem;
    • date of report;
    • physical location of problem;
    • nature of the problem;
    • number of similar reports received;
    • results of tests and other investigations on suspect or other samples; 
    • availability for investigation of suspect sample or other samples; and
    • other relevant factors
  • Details of the product
    • product name and description including dosage form, strength, ARTG number, pack size or type;
    • batch, serial number(s), donation number(s) or tissue bank number(s);
    • expiry date (if relevant);
    • manufacturer/Australian sponsor and contact telephone and facsimile numbers;
    • date manufactured;
    • date released;
    • quantity of the batch, date and amount released;
    • local distribution;
    • overseas distribution of product exported from Australia;
    • number of complaints received;
    • whether the product is meant to be sterile; and
    • sponsor's product/part/order code.
  • Risk assessment and proposed action
    • type of hazard, and assessment of risk to user;
    • action proposed by sponsor;
    • proposed recall classification;
    • proposed recall level; and
    • availability of alternative product

It is recognised that some of the information provided may be of a commercially sensitive or private nature and such information will be treated appropriately.

Book pagination