Batch BeaconUK recalls and safety alerts

Medicines defect noticeMHRA

Levetiracetam Accord 100mg/ml oral solution, Accord Healthcare Limited defect notice over a labelling error

Labelling or leaflet errorLow riskClass 4

Accord Healthcare Limited, UK has informed the MHRA that the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SPC) do not contain all the required safety information.

Check your product

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

8 identifiers listed for this notice.

  • Levetiracetam Accord 100mg/ml oral solution, Accord Healthcare Limited 300 mL Bottle

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • E243884
    • E244160
    • E243885
    • E244161
    ExpiryOn the carton, blister or label.
    • 31/08/2027
    • 30/09/2027
    First distributedOn the product, its label or its packaging.
    • Not Distributed
    • 16/01/2025

What to do now

There is an error on the label, carton or patient leaflet for Levetiracetam Accord 100mg/ml oral solution, Accord Healthcare Limited.

  1. Keep taking your medicine unless a healthcare professional tells you otherwise.
  2. Check the batch number and expiry date on your pack against the list on this page.
  3. If it matches, your pharmacist can swap it or arrange an alternative.
  4. Report suspected side effects to the MHRA Yellow Card scheme.

Why it matters. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.

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(25)A/40). Quoted as issued.

Summary

Accord Healthcare Limited, UK has informed the MHRA that the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SPC) do not contain all the required safety information.

The risk

DMRC reference number DMRC-35838218 Marketing Authorisation Holder

Advice for healthcare professionals

The quality of the oral solution is not impacted as a result of this issue, therefore the affected batches are not being recalled. Healthcare professionals involved in the dispensing of these products should, where possible, signpost new patients on these medicines to the missing safety information. A summary of the missing safety information can be found in the Appendix of this notice. Upon request, Accord Healthcare Limited will provide hard copies of the updated PIL to pharmacies so that any remaining stock in the dispensary can be supplemented with the correct PIL information. To request hard copies of the PIL, please contact 0800 373573.

Please follow the links to the correct documentation:

PIL: https://www.accord-healthcare-products.co.uk/document/pil-levetiracetam-accord-100mgml-oral-solution

SPC: https://www.accord-healthcare-products.co.uk/document/smpc-levetiracetam-accord-100mgml-oral-solution

Accord Healthcare Limited have confirmed that all future batches will contain the updated PIL.

Patients should continue to take medicines as prescribed by their healthcare professional. The product quality of the impacted batches is not affected, however there is some missing safety information in the Patient Information Leaflet (PIL) that patients should be aware of. A summary of the missing safety information can be found in the Appendix of this notice.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .

Advice for patients

Patients should continue to take medicines as prescribed by their healthcare professional. The product quality of the impacted batches is not affected, however there is some missing safety information in the Patient Information Leaflet (PIL) that patients should be aware of. A summary of the missing safety information can be found in the Appendix of this notice.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .

Open the MHRA notice

Questions

Why has Levetiracetam Accord 100mg/ml oral solution, Accord Healthcare Limited been recalled?

There is an error on the label, carton or patient leaflet for Levetiracetam Accord 100mg/ml oral solution, Accord Healthcare Limited. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.

How do I know if my medicine is affected?

Compare the batch code, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.

What should I do now?

Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.

Do I need a new prescription?

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.

Related notices