Source: MHRA /Gov.uk 20.7.23
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.
medac GmbH (t/a medac Pharma LLP)
Sodiofolin 50 mg/ml, solution for injection/infusion (400mg/8ml vial), PL 11587/0005
Active Pharmaceutical Ingredient: 54.65 mg/ml disodium folinate equivalent to 50 mg/ml folinic acid
Brief description of the 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 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.
For all medical enquiries, please contact medical information at medac Pharma LLP by email to email@example.com 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.
Defective Medicines Report Centre
10 South Colonnade
Telephone +44 (0)20 3080 6574
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