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Uniform recall procedure for therapeutic goods (URPTG), 2004 edition
F. Assessment of recall (strategy, classification and level)
Each recall is a unique exercise. However, in tailoring an appropriate recall strategy, there are a number of factors common to all recalls that need to be considered. These include the nature of the deficiency in the product, the incidence of complaints, consumer safety, distribution networks, recovery procedures, resources for corrective action and availability of alternative products.
In discussing the recall strategy, the sponsor and Co-ordinator should consider the factors which may affect the duration of the recall action, and a completion date should be agreed.
The actual implementation of the recall includes use of the basic steps which are summarised in section B and these will be common to all strategies.
Even when the required information (Section E) is available to the sponsor and to the Co-ordinator, the appropriate strategy may not be obvious and further liaison will then be necessary in order to attain an agreed course of action.
Recalls are classified according to the European classification system:
- Class I recalls occur when products are potentially life-threatening or could cause a serious risk to health.
Examples of Class I Defects
- Wrong product (label and contents are different products)
- Correct product but wrong strength, with serious medical consequences
- Microbial contamination of sterile injectable or ophthalmic product
- Chemical contamination with serious medical consequences
- Mix up of some products ("rogues") with more than one container involved
- Wrong active ingredient in a multi-component product with serious medical consequences
- Class II recalls occur when product defects could cause illness or mistreatment, but are not Class I.
Examples of Class II Defects
- Mislabelling e.g. wrong or missing text or figures
- Missing or incorrect information - leaflets or inserts
- Microbial contamination of non-injectable, non-ophthalmic sterile product with medical consequences
- Chemical/physical contamination (significant impurities, cross contamination, particulates)
- Mix up of products in containers ("rogues")
- Non-compliance with specification (e.g. assay, stability, fill/weight).
- Insecure closure with serious medical consequences (e.g. cytotoxics, child resistant containers, potent products).
- Class III recalls occur when product defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.
Examples of Class III Defects
- Faulty packaging e.g wrong or missing batch number or expiry date.
- Faulty closure
- Contamination - microbial spoilage, dirt or detritus, particulate matter.
Class I or Class II recalls are considered to be urgent safety-related recalls. A safety related recall is defined under the Trade Practices Act 1974 as the recall of 'goods of a kind which will or may cause injury to any person'. Where the recall is safety-related, there is a legal requirement to notify the Minister (via the ACCC). See Section M for further details.
Class III recalls are considered to be routine non safety-related recalls
Note: Each recall is a unique exercise and there may be occasions when the scope of a recall can be narrowed to particular customer groups. For example, in some specific situations, hospital pharmacies might be excluded from a recall applying to retail pharmacies. The classification is determined by consultation between the sponsor, the Australian Recall Co-ordinator, and where appropriate, the State/Territory co-ordinator. Expert advice should be sought where the nature of the hazard or its significance is not clear.
As with classification, the level (or depth) of a recall is to be determined by consultation between the sponsor, the Australian Recall Co-ordinator and, where appropriate the State/Territory co-ordinator. In determining the recall level, the principal factors to be considered are the significance of the hazard (if any), the channels by which the goods have been distributed, and the level to which distribution has taken place. Again, expert opinion may be necessary to determine the significance of the hazard.
In this procedure there are four levels of recall: wholesale, hospital, retail and consumer. One of these levels will be assigned to each recall.
- Medicine and device wholesalers
- State purchasing authorities etc.
- nursing homes, hostels and other institutions;
- clinical investigators and the institutions in which clinical investigations are performed;
- hospital pharmacists, blood banks, pathology laboratories, operating facilities, fractionators, human tissue banks and personnelin other hospital departments; and
- wholesale level.
- retail pharmacists;
- medical, dental and other health care practitioners;
- other retail outlets, e.g. supermarkets and health food stores; and
- wholesale and hospital levels.
- patients and other consumers; and
- wholesale, hospital and retail levels.