Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Sodiofolin 50 mg/ml solution for injection/infusion (400mg/8ml vial), EL (23)A/26
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.
MDR Number: MDR 009-06/23
Company name: medac GmbH (t/a medac Pharma LLP)
Product description: Sodiofolin 50 mg/ml, solution for injection/infusion (400mg/8ml vial), PL 11587/0005
SNOMED Code: 4800011000001106
Details of the affected batch:
|
Batch number |
Expiry date |
Pack size |
First distributed |
|
G220393B |
30/06/2025 |
1 |
12/10/2022 |
|
G220393C |
30/06/2025 |
1 |
30/03/2023 |
Active Pharmaceutical Ingredient: 54.65 mg/ml disodium folinate equivalent to 50 mg/ml folinic acid
Brief description of problem:
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 investigation remains ongoing.
Advice to Healthcare Professionals:
Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Advice to Patients:
No further action is required by patients as this is a Pharmacy and Wholesaler level recall. This product is administered by healthcare professionals directly. If you have concerns about a medicine you may be using, please contact your healthcare professional.
Patients who experience adverse reactions or have any questions about the 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 all medical enquiries, please contact medical information at medac Pharma LLP by email to info@medacpharma.co.uk or by telephone 01786 458086.
To access the full recall: