Class 2 Recall - Sodiofolin 50 mg/ml solution for injection/infusion

Medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in this notification due to particles detected during long-term stability tests.

Further to EL(23)/A26 medac GmbH (t/a medac Pharma LLP) have identified further batches that are impacted. medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in this notification due to particles detected during long-term stability tests. As stated in the Summary of Product Characteristics (SmPC): ‘Only clear solutions without visible particles should be used.’. These batches are being recalled as a precautionary measure and the root cause analysis investigation remains ongoing.

MHRA drug alert date: 21 August 2023

MHRA drug alert link:https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-medac-gmbh-t-slash-a-medac-pharma-llp-sodiofolin-50-mg-slash-ml-solution-for-injection-slash-infusion-100mg-slash-2ml-vial-el-23-a-slash-28?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=57648150-86b0-4190-81bc-49b6880f578d&utm_content=immediately

Further Information

For all medical enquiries, please contact medical information at medac Pharma LLP by email to info@medacpharma.co.uk or by telephone 01786 458086.