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Originator: MHRA Drug Alerts

From: Himal Makwana

Issue date: 25-Mar-2020 10:59:27

This alert has been issued to:
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Trusts (England) - Medical Director
  • Territorial CMOs in Northern Ireland, Scotland & Wales

  • 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
  • Director of Public Health
  • NHS Trusts (England) - Chief Executive
  • NHS 111 and Out of hours providers
  • Dispensing GP Practices
  • DHSC Supply Disruption - Medicines
  • Primary Care Networks

Action category: Class 4: For information

Title: CLASS 4 DRUG ALERT, FOR INFORMATION, MYLAN UK HEALTHCARE LIMITED, ZAMADOL SR 50MG PROLONGED-RELEASED CAPSULES

Broadcast content: Mylan UK Healthcare Ltd has informed us that the GTIN barcode applied on specific batches is incorrect.  The GTIN number that should have been allocated for these batches of capsules is 05060035240173, however, 05060035241477 was applied in error which scans the batches as Zamadol Melt Tablet 50mg.  All other information on the carton and label, including the EAN barcode is correct for the above batches of Zamadol SR 50 mg prolonged-release hard capsules.

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 Regional Offices: Please cascade this alert to Community Pharmacy and any Dispensing GP Practice not yet registered with CAS.
GP Practices: Please note this alert is for Dispensing GP Practices Only


Alert reference: EL (20)A/18

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency