When the leaflet is incomplete but the medicine is fine: acting on a Class 4 notification

Why this matters

Not every MHRA alert means pulling stock off the shelf. Some ask the dispensing team to keep supplying a medicine and to add something at the point of dispensing. These are easy to get wrong, because there is no quarantine box to remind anyone and the extra step has to be remembered on every prescription for months.

A notification published on 1 October 2026 is a good worked example. It concerns one manufacturer's levetiracetam granules for oral solution in sachets, a medicine used for epilepsy.

What the notification says

• It is a Class 4 Medicines Defect Notification, reference EL(26)A/40, issued by the MHRA.
• It covers Levetiracetam Neuraxpharm granules for oral solution in sachets in five strengths: 250 mg, 500 mg, 750 mg, 1000 mg and 1500 mg, in packs of 60 sachets.
• The patient information leaflet in the affected batches is missing some safety information that it should contain.
• The granules themselves are not affected. The notification says the quality of the medicine is unchanged.
• The stock is not being recalled. Affected batches can still be dispensed.
• The batch numbers are listed in the notification. Some of the listed batches had not yet been distributed when it was published, so affected packs may keep arriving.
• Packs with a corrected leaflet are expected from June 2027.

What is missing from the leaflet

The notification lists the gaps. In summary, the leaflet does not say that the medicine can be used in babies from one month old, and it leaves out some rare or very rare warnings and side effects. These relate to a rare genetic form of epilepsy that starts early in life, a serious reaction called neuroleptic malignant syndrome, obsessive compulsive disorder, and a severe allergic type reaction that can affect several organs.

You do not need to explain these to patients yourself. The supplementary letter does that, and questions about them go to the pharmacist.

What the dispensing team is asked to do

1. Read the whole notification and tell the pharmacist.
2. Check whether you stock this make of levetiracetam granules, and compare your stock with the batch numbers listed. Remember bagged prescriptions waiting for collection and any owings.
3. Keep dispensing affected batches as normal. Do not quarantine or return them.
4. Give the patient a copy of the supplementary letter every time you dispense an affected pack, not only the first time.
5. Get copies of the letter. It can be downloaded from the notification page, and printed copies can be requested from the manufacturer using the contact details in the notification.
6. Record what your team did, following your pharmacy's procedure for alerts.

Making the extra step stick

The risk with this kind of notification is that it works for a week and then fades. Corrected packs are not expected until June 2027, so the step needs to survive holidays, locums and new starters. Ideas to discuss with your pharmacist and team:

• Keep printed letters with the stock, for example in a wallet on the shelf edge, so the letter is in your hand when the pack is.
• Add a shelf note with the alert reference and the action.
• If your pharmacy system allows it, add a product note or prompt.
• Brief the whole team, including delivery drivers if packs go out by delivery, and include the notification in handover for anyone who was away.
• Recheck the batch list when new stock arrives, and reorder letters before they run out.

What to say to patients and carers

Keep it calm and factual. The message from the notification is that the medicine is unchanged, the leaflet in the box is missing some information, and the letter fills the gap. Patients should keep taking their medicine as prescribed.

Epilepsy medicines should never be stopped suddenly because of a worry about a leaflet. If a patient or carer is anxious, has questions about side effects, or says their condition has changed or worsened, refer them to the pharmacist. Suspected side effects can be reported through the Yellow Card scheme.

When to involve the pharmacist

• When the notification first arrives, and for any decision about how your pharmacy will act on it
• Any patient or carer question about the missing information, side effects or whether to keep taking the medicine
• Any report of worsening seizures, unexpected changes in mood or behaviour, or feeling unwell
• If you have no letters to give out with an affected pack

PPets learning connection

Responding to safety alerts, stock management and governance are covered in the Level 3 Diploma for pharmacy technicians. Our guide to how medicines recalls work explains the recall classes in more detail.

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 Class 4 Medicines Defect Notification EL(26)A/40: Levetiracetam Neuraxpharm granules for oral solution in sachet (Open Government Licence v3.0)
• MHRA alerts, recalls and safety information

Related from PPets

• Level 3 Diploma for pharmacy technicians
• Free resources

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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