Medicines recallMHRA
Sodiofolin 50 mg/ml solution for injection/infusion, (100mg/2ml vial) recalled over possible contamination
medac GmbH (t/a medac Pharma LLP) is recalling further batches due to particles detected during long-term stability tests.
Check your product
Only products that match these details are covered. Have your pack in front of you.
11 identifiers listed for this notice.
Sodiofolin 50 mg/ml solution for injection/infusion, (100mg/2ml vial) 1
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- D210211C
- D210211D
- D210211F
- D210211G
- D210211H
- ExpiryOn the carton, blister or label.
- 30/04/2024
- First distributedOn the product, its label or its packaging.
- 16/02/2022
- 03/03/2022
- 04/04/2022
- 13/06/2022
- 17/06/2022
What to do now
The concern with Sodiofolin 50 mg/ml solution for injection/infusion, (100mg/2ml vial) is contamination or loss of sterility.
- 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.
- If it matches, your pharmacist can swap it or arrange an alternative.
- Report suspected side effects to the MHRA Yellow Card scheme.
Why it matters. Contamination matters most for injections, eye drops and products used on broken skin, where it could cause infection.
Symptoms and when to get help
Look out for
- redness, swelling or pain where the product was used
- a high temperature
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
Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.
If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(23)A/28). Quoted as issued.
Summary
medac GmbH (t/a medac Pharma LLP) is recalling further batches due to particles detected during long-term stability tests.
The risk
MDR number 040-07/23 Company name
Advice for healthcare professionals
Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
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.
Advice for 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.
Open the MHRA notice
Questions
Why has Sodiofolin 50 mg/ml solution for injection/infusion, (100mg/2ml vial) been recalled?
The concern with Sodiofolin 50 mg/ml solution for injection/infusion, (100mg/2ml vial) is contamination or loss of sterility. Contamination matters most for injections, eye drops and products used on broken skin, where it could cause infection.
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?
Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.