Recalls

This page provides information on what constitutes a recall and how recalls are carried out on the Irish market.

A product recall is defined as the retrieval from the marketplace of a batch or batches of any medicinal product, whether for human or veterinary use, which is/are the subject of a quality defect. General information on quality defects is available on our defects page.

The Market Compliance Section of the HPRA Compliance Department is responsible for co-ordinating all aspects of medicinal product recalls in Ireland.  Product recalls are classified according to the potential impact on patient and/or animal health of the defect issue giving rise to the need for a recall. The seriousness of the defect determines the timelines for issuance of recall communications and to whom they are issued. The QDR group works closely with companies to ensure that recall communications are issued in a timely manner and with the required content.

Recalls of products on the Irish market occur to different levels, depending on the risk posed by the quality defect. The majority of recalls occur to retail or pharmacy level.

Typically, communications for retail / pharmacy level recalls take the form of the following:

• Recall letter to all retailers / pharmacies to which the affected batch(es) were distributed. The letters are sent by post by the company responsible for placing the batch(es) on the Irish market and are approved by the QDR group
• If contact details for the retailer / pharmacy are available, the recall letter may be preceded by a phone call or email, in preparation for the recall action

Where a potential serious risk to patient or animal health exists, the recall may extend to patient / user level. Communications are usually sent to all potentially affected groups: wholesalers, community and hospital pharmacists, doctors, patients. Patient level recalls typically account for between 5% and 15% of the total recalls in a given year and the majority are confined to a small number of units. During a patient level recall, the following actions may be performed:

• Patients, where possible, may be contacted by phone by their pharmacist / doctor and asked to return affected units for replacement, free of charge
• Rapid electronic communications can be used, including website and press statements, to relay the recall message to patients who are not contactable by other means

• For large patient level recalls, the HPRA can utilise patient groups, to forward recall communications to their members

Return of Recalled Packs

A recall will only occur if replacement stock or a replacement product is available for the patient. Often, recalls cannot be carried out if the risk associated with a patient returning their medicine is greater than that posed by the quality defect itself. When a recall does occur, packs are returned back through the original supply chain, for replacement or refund. Pharmacists should carefully read the instructions on recall letters, to ensure that affected packs are identified, quarantined and returned in a timely manner.

Where a quality defect affects a batch or batches distributed only to a limited, identifiable number of customers such as retailers, pharmacies, wholesalers, recall communications will be sent to those customers only. Where the extent of the defect is large and all customers are difficult to identify, the associated recall communications are sent to all potential customers. This is called a blanket recall. Where patient level recalls are involved, communications would typically include HPRA website and/or press statements.

If you have any queries on the recall of medicines, you can contact us at the below:

Email: qualitydefects@hpra.ie

Telephone: (01) 6764971