How a medicines recall reaches your dispensary, and what you do next

Why this matters

When a medicine is found to be defective, the pharmacy team is the part of the system that physically finds the stock and stops it reaching patients. Pharmacy technicians and dispensers usually do that work, so it helps to understand what the different alerts mean and how fast you need to move.

Who issues recalls

In the UK, recalls and notifications for medicines are issued by the Medicines and Healthcare products Regulatory Agency (MHRA). They are published on GOV.UK and sent out through the Central Alerting System and other routes, so your pharmacy may receive the same alert by email, through your head office or wholesaler, and through your pharmacy system.

The recall classes

• Class 1, immediate action. The defect presents a risk of death or disability. These are usually accompanied by a National Patient Safety Alert.
• Class 2, action within 48 hours. The defect may cause mistreatment or harm, but is not life threatening or serious. An example is a pack labelled with the wrong strength.
• Class 3, action within 5 days. The defect is unlikely to cause harm and the recall is carried out for other reasons, such as a wrong expiry date on the packaging.
• Class 4, caution in use. Usually a minor packaging or leaflet defect. Stock is not normally returned, but you need to read what the alert asks you to do.
• Company-led recalls. The manufacturer contacts affected customers directly when it knows exactly who received the stock.

Each alert also says how far the recall goes, for example whether stock should be recalled from pharmacies and wholesalers only, or from patients as well.

What to do when an alert arrives

1. Read the whole alert. Note the product, strength, form, pack size, batch numbers and expiry dates affected.
2. Tell the pharmacist.
3. Check everywhere stock could be: dispensary shelves, the fridge, the controlled drugs cabinet, robot or automated storage, split packs, the retrieval shelves of bagged prescriptions, monitored dosage systems and owings.
4. Quarantine affected stock straight away. Separate it, label it clearly 'Recalled. Do not use', and follow the alert's instructions for return.
5. If the recall is to patient level, follow your SOP and the pharmacist's direction for identifying and contacting patients using dispensing records.
6. Record what you did: the alert reference, date, who checked, what was found, including a nil return if you had none.
7. Keep the record where your SOP says, so it can be shown at inspection.

Common pitfalls

• Checking the shelf but forgetting bagged prescriptions waiting for collection
• Not recording a nil return
• Assuming someone else has dealt with it
• Missing alerts that arrive when the usual person is away. Make sure more than one person receives them
• Returning recalled controlled drugs without following the usual controlled drug record keeping

PPets learning connection

Stock management, governance and responding to safety alerts are covered in the Level 3 Diploma for pharmacy technicians. Our free GPhC inspection evidence template can be used to record how your team handles alerts.

Record this as CPD

Registered pharmacy technicians can use this article towards GPhC revalidation, as an unplanned CPD entry or as the starting point for a reflective account. Pharmacy assistants and trainees can use it as evidence of reflective practice. Note down three things:

1. What you learned from this article
2. How you have applied it, or will apply it, in your own role
3. The benefit to the people who use your pharmacy's services

Sources and further reading

• MHRA: safety communications concerning medicines, medical devices and other healthcare products
• MHRA alerts, recalls and safety information

Related from PPets

• Level 3 Diploma for pharmacy technicians
• Free resources, including the GPhC inspection evidence template

This article is for general educational purposes only. It is not legal advice, professional regulatory advice or clinical advice about an individual patient. Always follow your pharmacy's SOPs and check current official guidance and product information.

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