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Originator: MHRA Drug Alerts

From: Sze Mun Tan

Issue date: 16-Dec-2020 14:59:16

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
  • Community Pharmacy
  • Primary Care Networks

Action category: Class 2: Action within 48 hours

Title: CLASS 2 DRUG ALERT, ACTION WITHIN 48 HOURS, MERCK SHARP & DOHME LIMITED, ZERBAXA 1G/0.5G POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION, EU/1/15/1032/001

Broadcast content: Merck Sharp & Dohme Limited is recalling specific batches due to the presence of Ralstonia pickettii in recent batches that were manufactured. These specific batches are recalled as a precautionary measure whilst investigations into the microbiological quality of the distributed products are underway.

The potential for contamination of the listed batches is low. If R. pickettii is found to be present, the risk that these products would contain viable R. pickettii in a level that could cause serious adverse health consequences is considered to be low.

R. pickettii is a gram-negative, non-motile, non-spore-forming, rod-shaped bacteria found in soils, rivers and lakes. It is also present in biofilms bacteria (collective of one or more types of microorganisms that can grow on surfaces) in industrial plastic water systems.

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.

If patients experience a worsening of symptoms or other suspected side effects during therapy with Zerbaxa, these should be reported via the Yellow Card scheme.

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 this alert is for Dispensing GP Practices only


Alert reference: EL (20)A/60

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency