Medicines and Medical Devices Recalls and Notifications

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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 1Immediate action on receiptPotentially life threatening or present a serious risk to healthProduct will be recalled, possibly by direct uplift
Class 2Action within 48 hoursCould present a risk to healthProduct will be recalled  usually via wholesalers
Class 3Action within 5 daysPoses  a reduced risk to healthProduct will be recalled  usually via wholesalers
Class 4Action within 5 daysNo threat to patients, advice usually issued about useProduct 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.

MHRA