Medicines and Medical Devices Recalls and Notifications
All recalls and notifications are defined by their classification, this is in relation to the time scale in which it needs to be acted upon and the level of harm potential.
|
Class 1 |
Immediate action on receipt |
Potentially life threatening or present a serious risk to health |
Product will be recalled, possibly by direct uplift |
|
Class 2 |
Action within 48 hours |
Could present a risk to health |
Product will be recalled usually via wholesalers |
|
Class 3 |
Action within 5 days |
Poses a reduced risk to health |
Product will be recalled usually via wholesalers |
|
Class 4 |
Action within 5 days |
No threat to patients, advice usually issued about use |
Product will not be recalled |
Numark keeps an up to date directory of recent recalls which can be accessed through the following link:
Medicine Recalls and Notifications
An SOP is available for use within the pharmacy with processes for dealing with medicine recalls and notifications:
Patient Safety and Drug-Device Alerts SOP
Field Safety Notices are issued on a weekly basis by the Medicines and Healthcare products Regulatory Agency (MHRA). These relate to issues with medical devices. They can be accessed from the MHRA website.