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Voluntary Recall

Recalls of registered agvet chemical products may be proposed or undertaken by the manufacturer or supplier at any time for a variety of reasons. A recall is a risk mitigation activity and may occur in response to an identified manufacturing quality or other issue related to specific batches of a chemical product. Such issues could be low-level noncompliance with statutory requirements, but some may be noncompliant with the manufacturer's own standards. Provided the issue is one of low-level noncompliance and the manufacturer's mitigation strategy will appropriately manage any identified risk, the APVMA should be advised but does not need to become involved.

Voluntary recalls are effectively self-reported matters, and we are willing to assist the notifier to manage the problem effectively, if required. Most recalls are conducted voluntarily, without exercise of our recall powers. We encourage the reporting of potential voluntary recalls to us as soon as a problem is identified. Once it is notified the APVMA will determine whether a voluntary recall is appropriate based on its own assessment of potential risk. Notification of a Potential or Actual Recall of an Agricultural or Veterinary Chemical Product (KP40_F33) (DOC, 47kb).

Compulsory Recalls

The ability to recall defective or noncompliant (including unregistered) products is fundamental to risk management. The term 'recall' does not refer just to the retrieval or return of products from the marketplace or consumers. Recalls can also include formal requirements or notices not to supply or to stop supply.

The full suite of powers available to the APVMA for recalls is detailed in section 101 (Recall of unregistered products), section 102 (Recall of registered products) and section 103 (Recall of products with unapproved labels) of the Code Act.

Recalls and similar powers address product risk and are generally used by the APVMA solely as a precautionary protective measure. Although the issue of a recall may impose a burden on a product holder or supplier, recalls are not intended to be punitive.

The APVMA has developed guidelines for the recall of agricultural and veterinary chemicals to assist people and companies to determine whether a recall is required and how to recall products effectively. Guidelines for the Recall of Agricultural and Veterinary Chemicals - February 2009 (PDF, 522kb).

The costs of any aspect of a recall (voluntary or compulsory) are the responsibility of the person or company involved. This includes costs for any advertising needed to mitigate risk as part of a compulsory recall.

When deciding whether advertising a product recall is required, we consider the ability of the responsible company to contact all affected parties. For example, when a recall relates to an agvet chemical product with an identified lack of efficacy, and the product is distributed by mail order directly to end users, we are likely to require direct correspondence from the supplier to each customer, rather than advertisements in national media. If the product is distributed through retail outlets to the general public, we are likely to require notices at the point of sale and advertisements in print media to ensure an effective recall.

'A compulsory recall of a product involves oversight by the APVMA. Compulsory recalls are undertaken to ensure the safety of people, animals, the environment and international trade'

Compulsory recalls are issued by the APVMA when:

  • a risk to the public or environmental health exists
  • the product in question is unregistered
  • voluntary action is insufficient to mitigate risk and therefore an unacceptable risk presents.

A recall notice lists the actions a person or company must take, including:

  • the level of recall (wholesale, retail or end user)
  • the future fate of the material (disposal, export etc.)
  • the advertising or dissemination of the recall notice (local or national advertising, including in new
  • the form and wording of any correspondence or advertisement informing affected parties
  • the timeframe for recall actions.

Prompt reporting of product issues demonstrates a high level of product stewardship.