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Originator: MHRA Drug Alerts

From: Sze Mun Tan

Issue date: 14-Oct-2020 10:29:11

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
  • Primary Care Networks

Action category: Class 2: Action within 48 hours

Title: CLASS 2 DRUG ALERT, ACTION WITHIN 48 HOURS, SANOFI, EPILIM 500MG GASTRO-RESISTANT TABLETS, PL 04425/0303

Broadcast content: Sanofi is recalling specific batches of Epilim 500mg Gastro-Resistant Tablets as a precautionary measure due to out of specification results for disintegration test during routine stability testing.

Advice for healthcare professionals
Stop supplying the listed batches immediately. Quarantine all stock and return it to 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 that this alert is for Dispensing GP Practices only


Alert reference: EL (20)A/48*

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency