Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Sodiofolin 50 mg/ml solution for injection/infusion, (100mg/2ml vial), EL (23)A/28
medac GmbH (t/a medac Pharma LLP) is recalling further batches due to particles detected during long-term stability tests.
MDR Number: 040-07/23
Company name: medac GmbH (t/a medac Pharma LLP)
Product description: Sodiofolin 50 mg/ml solution for injection/infusion, (100mg/2ml vial)
Details of the affected batches:
|
Batch Number |
Expiry Date |
Pack Size |
First Distributed |
|
D210211C |
30/04/2024 |
1 |
16/02/2022 |
|
D210211D |
30/04/2024 |
1 |
03/03/2022 |
|
D210211F |
30/04/2024 |
1 |
04/04/2022 |
|
D210211G |
30/04/2024 |
1 |
13/06/2022 |
|
D210211H |
30/04/2024 |
1 |
17/06/2022 |
Brief description of problem:
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.
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: Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Sodiofolin 50 mg/ml solution for injection/infusion, (100mg/2ml vial), EL (23)A/28