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 name
Sodiofolin 50 mg/ml solution for injection/infusion, (100mg/2ml vial)
SNOMED Code
4799711000001101
| 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 |
Active Pharmaceutical Ingredient: 54.65mg/ml disodium folinate equivalent to 50mg/ml folinic acid.
Brief description of the 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 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.
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.
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.
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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