Class 4 Medicines Defect Notification: Levetiracetam Accord 100mg/ml oral solution, Accord Healthcare Limited, UK, EL(25)A/40
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.
DMRC Number: DMRC-35838218
Company name:Accord Healthcare Limited, UK
Product description: Levetiracetam Accord 100mg/ml oral solution - PL: 20075/0386, SNOMED code: 35241511000001104, GTIN: 05055565718797
Details of the affected batches:
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| E243884 | 31/08/2027 | 1 vial pack | Not Distributed |
| E244160 | 31/08/2027 | 1 vial pack | Not Distributed |
| E243885 | 31/08/2027 | 1 vial pack | 16/01/2025 |
| E244161 | 30/09/2027 | 1 vial pack | Not Distributed |
Brief description of problem:
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 information missing in the various sections of the PIL and SPC is summarised in the Appendix of this notice.
The batches listed as ‘not yet distributed’ have also been manufactured with the incorrect PIL. The MHRA, in discussion with the Department of Health and Social Care, considers these products critical for patients, therefore these batches will be distributed without further repackaging. They are therefore included in the notification.
Advice to 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 the recall document. 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
Accord Healthcare Limited have confirmed that all future batches will contain the updated PIL.
Advice to 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 the recall 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.
Company contacts for further information:
For medical information enquiries please contact: Accord Medical Information Department on 01271 385257, email- medinfo@accord-healthcare.com.
For stock control enquiries please contact: Accord- Customer Services Team on 0800 373573.
To access the full recall: Class 4 Medicines Defect Notification: Levetiracetam Accord 100mg/ml oral solution, Accord Healthcare Limited, UK, EL(25)A/40