Epistatus 2.5 mg oromucosal solution recall (Aug 2023)

Check your product

Only products that match these details are covered. Have your pack in front of you.

Type the code from your pack

4 identifiers listed for this notice.

Epistatus 2.5 mg oromucosal solution, pre-filled syringe (PFS) 1 x 0.25ml PFS
Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- 230327A2
Product licenceThe PL number on the carton.
- PLGB 16786/0015
ExpiryOn the carton, blister or label.
- 09/2024
First distributedOn the product, its label or its packaging.
- 05/06/2023

What to do now

Some batches of Epistatus 2.5 mg oromucosal solution, pre-filled syringe (PFS) may not contain the right amount of active ingredient.

Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
Compare the batch number printed on the box or label with the batches listed here.
If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
Any side effect you think is linked can be reported through the Yellow Card scheme.

Why it matters. A medicine that is weaker than stated may not control the condition it treats; one that is stronger may cause side effects.

Symptoms and when to get help

Look out for

a side effect you have not had before
your condition not being controlled as well as usual

Get help urgently

signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111

This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.

Replacements and prescriptions

If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself.

Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(23)A/32). Quoted as issued.

Summary

Veriton Pharma Limited is recalling a specific batch of Epistatus (midazolam) 2.5mg Oromucosal Solution (pre-filled oral syringes) due to confirmed out of specification results related to the product appearance.

The risk

MDR number MDR 047-08/23 Company name

Advice for healthcare professionals

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Healthcare settings should consider using other batches or midazolam from alternative providers to administer emergency doses as required. The opalescent product in the impacted batch has been shown to contain sufficient midazolam and could be used in an emergency where alternate medicine is not available. The recall is being carried out as a precautionary measure to mitigate any further concerns with syringes that are not as described in the SmPC.

One batch of Epistatus (midazolam) 2.5mg oral syringes has been recalled from pharmacies as a precaution due to the potential for cloudiness or crystallisation.

Patients and carers do not need to return this medicine but are reminded of the importance of following the instructions in the Patient Information Leaflet (PIL) related to checking the physical appearance of the product before use. Do not use or give this medicine if you notice that the syringe has been damaged or if the solution is not clear (for example, it is cloudy or white particles are present). In an emergency, please contact the emergency services if you have any concerns.

A copy of the Patient Information Leaflet (PIL) can be found in the product packaging or obtained from PIL: Epistatus 2.5mg (Midazolam) Oromucosal Solution

Patients and carers are always advised to follow the information within the PIL on what to do if the patient’s condition does not improve:

Seek emergency medical assistance – telephone for an ambulance immediately – if the patient’s seizure does not stop shortly after administering Epistatus.

Follow the instruction you have received from the patient’s doctor on how to act in this situation. A second dose of Epistatus should not be given without medical advice.

If the patient’s condition improves but the seizure (‘fit’) then starts again or if you give more Epistatus that you should:

Seek emergency medical assistance – telephone for an ambulance immediately.

Further guidance on signs and symptoms to look out for is available in the Patient Information Leaflet, however patients and carers should always contact the emergency services in all circumstances: PIL: Epistatus 2.5mg (Midazolam) Oromucosal Solution

If you are taking this batch of product and you experience any adverse reactions or insufficient control of symptoms, please seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .

Advice for patients