Product Recalls

Reporting Recall Issues: To obtain contact details to report a recall or a potential recall issue, click here.

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, another non-compliance with the marketing authorisation, or a safety or efficacy issue. Quality related issues, which can lead to a batch or product recall, are known as quality defects.

The Market Compliance Section of the IMB Compliance Department is responsible for co-ordinating all aspects of medicinal product recalls in Ireland. Product recalls are categorised according to the potential impact on patient and public health of the issue giving rise to the need for a recall.

There are three Classes of recalls.

- Class I Recalls – generally for Critical Quality Defect issues
These are recalls which result from quality defects of medicinal products which are potentially life-threatening or could cause a serious risk to health;

- Class II Recalls – generally for Major Quality Defect issues
These are recalls due to quality defects which could cause illness or mistreatment but are not Class I;

- Class III Recalls - generally for Minor Quality Defect issues
These are recalls due to quality defects which are not likely to pose a significant hazard to health but where a recall has been initiated for other reasons.

The timelines and actions associated with the above classes of recalls are summarised below. Please note that these details are general guidelines only. All product recalls are considered on a case by case basis, and actions and timelines pertaining to individual cases may differ from those outlined below.

Additional guidance on recalls and recall related issues is given in the IMB Note for Guidance on Product Recalls.

Summary of the Notification Period, Method and Extent for the Different Classes of Recalls & Caution in Use Notifications

Recall Classification	Class I	Class II	Class III	Caution in Use Notification
Notification Period	Within 24 hours	Within 72 hours	Within 5 days	Within 5 days
Method of Notification	Phone & fax, Radio/TV (if necessary), press announcements followed by letter	Phone (if necessary) followed by fax/letter	Fax/letter	Letter
Extent of Notification	Wholesalers, pharmacies, other medical practitioners and professional groups, patients, other retailers	Wholesalers, pharmacies, hospitals, possibly to Doctor/Dentist or Veterinarian level, possibly other retail outlets	Wholesalers, possibly pharmacies and other retail outlets	Pharmacies, possibly medical practitioners, possibly wholesalers
Method of Retreival of Recalled Stock	Direct uplift of stock	Via wholesaler	Via wholesaler	Not applicable

The Irish Medicines Board - www.imb.ie

Product Recalls