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Originator: MHRA Drug Alerts

From: Himal Makwana

Issue date: Originally issued on 23-Oct-2019 10:50:42. This version was issued on 23-Oct-2019 10:50:42

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
  • Regional Directors of Public Health

  • 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
  • GP - Locum
  • GP Practices
  • DHSC Supply Disruption - Medicines

Action category: Class 2: Action within 48 hours

Title: CLASS 2 DRUG ALERT, ACTION WITHIN 48 HOURS, PFIZER LIMITED, SAYANA PRESS 104MG/0.65ML SUSPENSION FOR INJECTION

Broadcast content:

Pfizer Limited is recalling selected batches of Sayana Press for subcutaneous (SC) injection due to the observation of injectors with moisture outside the sealed area with a wet label, immediately after their removal from the pouch and injectors with a temporarily unreadable expiry date on the unit label.

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: GP Practices: Please share this alert within your practice to assist the management of patients who use these medicines
NHS England Regional Offices: Please cascade this alert to community pharmacies.


Alert reference: EL (19)A/28

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency