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Originator: MHRA Drug Alerts

From: Sandra Bax - Medicines and Healthcare Products Regulatory Agency

Issue date: 12-Mar-2018 10:58:47

This alert has been issued to:
  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • 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

  • 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

Action category: Class 3: Action within 5 days

Title: DRUG ALERT CLASS 3 (ACTION WITHIN 5 DAYS); ASTRAZENECA; LYNPARZA CAPSULE 50MG (OLAPARIB); EU/1/14/959/001

Broadcast content:

AstraZeneca is recalling batch NG327 as the level of olaparib polymorphic form L exceeds the registered specification limit. As a precautionary measure, the other listed batches are also being recalled as they may exceed the limit before the end of their shelf life.

Full details of the drug alert are included in the attached PDF file. The AstraZeneca letter to healthcare professionals is also attached for information. Please forward to listed recipients. This information is also published on the MHRA website https://www.gov.uk/drug-device-alerts



Alert reference: EL(18)A/06

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


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Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency