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Originator: MHRA Drug Alerts

 
From: Himal Makwana

Issue date: 29-Jul-2020 10:59:32

Action by recipients:
  • NHS Regional Offices
  • NHS Foundation Trusts (England) - Medical Director
  • NHS Trusts (England) - Medical Director

Information to recipients:
  • 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, KYOWA KIRIN LIMITED, ABSTRAL 200 MICROGRAM SUBLINGUAL TABLET, PL 16508/0031

Broadcast content:
Kyowa Kirin Limited is recalling a specific batch as a precautionary measure, due to the reports of double tablets in a single blister pocket. This was identified during reference sample inspection and there is a potential low risk of accidental double dosage.

Advice to healthcare professionals:
Stop supplying the affected batch immediately. Quarantine all remaining stock and return these 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 Pharmacy.
GP Practices: Please note this alert is relevant for Dispensing GP Practices only.


Alert reference: EL (20)A/34

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency