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Originator: MHRA Drug Alerts

From: Sze Mun Tan

Issue date: 29-Dec-2020 09:59:24

This alert has been issued to:
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Trusts (England) - Medical Director

  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • NHS Foundation Trusts (England) - Chief Executive
  • MHRA (Medicines) Drug Alerts - Non-NHS Recipients
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Regional Directors of Public Health
  • Director of Public Health
  • NHS Trusts (England) - Chief Executive
  • GP - Locum
  • NHS 111 and Out of hours providers
  • Dispensing GP Practices
  • DHSC Supply Disruption - Medicines
  • Community Pharmacy
  • Primary Care Networks

Action category: Class 2: Action within 48 hours

Title: CLASS 2 DRUG ALERT, ACTION WITHIN 48 HOURS, MEDAC GMBH (T/A MEDAC PHARMA LLP), SODIOFOLIN 50MG/ML SOLUTION FOR INJECTION (2MG VIAL), PL 11587/0005

Broadcast content: 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 listed batches are being recalled as a precautionary measure. 

Advice for healthcare professionals:
Stop supplying the batch above immediately. Quarantine all stock and return it your supplier using your supplier's approved process.

Full details of the drug alert are included in the attached PDF file. Please forward to listed recipients. This information is also published on the MHRA website https://www.gov.uk/drug-device-alerts


Additional information: NHS England and NHS Improvement Regional Offices: Please cascade this alert to Community Pharmacies.
GP Practices: Please note this alert is for Dispensing GP Practices only.


Alert reference: EL (20)A/61

Attachments:
Cascade to:
  • #COMMUNITYPHARMACISTS#
  • #DISPENSING GP#
  • #HospitalPharmacy#


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency