Class 2 Medicines Recall, medac GmbH (T/A medac Pharma LLP) Sodiofolin 50mg/ml Solution for Injection 100mg/2ml, PL 11587/0005
- The problem
- medac Pharma LLP is recalling a specific batch of products due to some inspected vials showing hairline damage to the shoulder of the vials.
- What to do
- Check the batch number on your pack against the list below. Do not stop taking a prescribed medicine without talking to your pharmacist, GP or prescriber first – they can check your supply and swap it if needed.
Product information
PL Number(s)
- Sodiofolin 50mg/ml Solution for Injection 100mg/2ml, PL 11587/0005
MDR Number
MDR 038-11/20
Company name
medac GmbH T/A medac Pharma LLP
Product description
Sodiofolin 50mg/ml Solution for Injection 100mg/2ml
- Batch Number: B190132C
- Expiry Date: 28/02/2022
- Pack Size: 1 x 1
- First Distributed: 15/07/2020
Active Pharmaceutical Ingredient: disodium folinate
Brief description of the problem
medac Pharma LLP is recalling the above batch of products due to some inspected vials showing hairline damage to the shoulder of the vials. So far, the company has not received any reports of damage for marketed products. However, as this defect may impact on the sterility of the product, the above batch is being recalled as a precautionary measure.
Advice for healthcare professionals
Stop supplying the above batch immediately. Quarantine all stock and return it to your supplier using your supplier’s approved process.
Further Information
For more information or medical information queries, please contact info@medacpharma.co.uk or telephone 01786 458086.
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Download the document
Updated 11 November 2020. This page summarises an official notice. Details can change – always follow the official notice.