Reporting a Medicine Quality Issue

Issues in relation to the quality of a medicine are known as quality defects. A quality defect may affect the quality, safety or effectiveness of a medicine. As a result, there may be an increased risk to the safety of patients or animals. Sometimes, a quality defect is such that the medicine may be recalled from the market, and in these instances, the IMB oversees the recall of the product.

Examples of quality defects could be:

• Packs of a medicine that are missing the patient information leaflet
• Discoloured syrups
• Discoloured or mouldy tablets
• Blister strips that are empty or missing tablets or capsules
• Incorrect or confusing information on the product packaging

Patients or members of the public who have concerns about the quality of a medicine should firstly consult with their pharmacist or doctor, who may then decide to contact the IMB. If you wish, you can report a quality concern with a medicine directly to the IMB, by using our online form. You can also write to us at the contact details below or you can telephone us.

The IMB contact person for quality defects in medicines is:

Ms. Aoife Farrell
Quality Defects & Recall Manager,
Irish Medicines Board
Kevin O'Malley House, Earlsfort Centre,
Earlsfort Terrace,
Dublin 2

Tel: +353 1 6764971
Fax: +353 1 6767836
recallsandqualitydefects@imb.ie

The Irish Medicines Board - www.imb.ie

Reporting a Medicine Quality Issue