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Originator: MHRA Drug Alerts

From: Sze Mun Tan

Issue date: 03-Dec-2020 11:59:15

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 3: Action within 5 days

Title: CLASS 3 DRUG ALERT, ACTION WITHIN 5 DAYS, LUPIN HEALTHCARE (UK) LIMITED, SIMVADOR 10MG, 20MG, 40MG TABLETS, PL 35507/0012, PL 35507/0013, PL 35507/0014

Broadcast content: Lupin Healthcare (UK) Limited has informed us that the affected batches above (also distributed by Discovery Pharmaceuticals /Dexcel Pharma Limited) have been packaged with a version of patient information leaflet that does not include the most up to date safety information.

There are no concerns with the quality, safety and efficacy of the product. However, the affected batches are being recalled due to concerns around the omission of the safety information. Please refer to the alert for the missing information in the PIL.

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

As a general reminder, pateitns who experience side effects from taking any medicines should be encouraged to report a suspected problem or incident via the Yellow Card Scheme and seek medical advice accordingly.

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/57

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency