Dealing with faulty medicines: Medicines & Medical Device Regulation

The MHRA’s Defective Medicines Report Centre (DMRC) issues alerts to healthcare professionals,

hospitals, GP surgeries, and wholesalers to tell them when a medicine is being recalled or when there are concerns about the quality that will affect its safety or effectiveness. These alerts are graded according to the seriousness of the threat to the public’s health: Class 1 requires immediate recall, because the product poses a serious or life threatening risk to health. Class 2 specifies a recall  within 48 hours, because the defect could harm the patient but is not life threatening. Class 3 requires action to be taken within 5 days because the defect is unlikely to harm patients and is being carried out for reasons other than patient safety. Class 4 alerts advise caution to be exercised when using the product, but indicate that the product poses no threat to patient safety. Most recalls fall into classes 2 or 3.