Class 2 Medicines Recall, medac GmbH (T/A medac Pharma LLP) Sodiofolin 50mg/ml Solution for Injection 100mg/2ml, PL 11587/0005, EL (20) A/61

Medac Pharma LLP is recalling specific batches of products due to some inspected vials showing hairline damage to the shoulder of the vials. This is a second alert for further batches identified.

Product information

PL Number

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 Expiry Date Pack Size First Distributed
L180633D 31/10/2021 1 x 1 05/06/2019
L180633L 31/10/2021 1 x 1 08/10/2019
L180633P 31/10/2021 1 x 1 09/02/2020
M190771B 30/11/2022 1 x 1 08/11/2020

Active Pharmaceutical Ingredient: disodium folinate

Brief description of the problem

Further to Drug Alert EL (20)A/52 issued on 11 November 2020, medac Pharma LLP is recalling further batches of products following inspection of 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 batches are being recalled as a precautionary measure.

Advice for healthcare professionals

Stop supplying the batch above 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

Class 2 Medicines Recall, medac GmbH (T/A medac Pharma LLP) Sodiofolin 50mg/ml Solution for Injection 100mg/2ml, PL 11587/0005, EL (20) A/61

Updates to this page

Published 29 December 2020