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Originator: MHRA Drug Alerts

From: Sze Mun Tan

Issue date: 04-Aug-2020 12:59:08

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
  • Primary Care Networks

Action category: Class 2: Action within 48 hours

Title: CLASS 2 DRUG ALERT, ACTION WITHIN 48 HOURS, PHARMARAM LTD, CLEXANE 4,000IU (40MG)/0.4ML SYRINGES, PLPI 33652/0067

Broadcast content: Pharmaram Ltd has informed us that a specific batch of Clexane 4,000IU (40mg)/0.4ml Syringes has an error on the labelling affixed to the plastic blister packaging encasing the syringe. The label incorrectly states "Clexane 6,000IU (60mg)/0.6ml Syringes" when it should have stated "Clexane 4,000IU (40mg)/0.4ml Syringes". The outer carton states the correct strength; the batch number and expiry date are also correct and match the details in the labelling.

Advice for healthcare professionals:
  • Stop supplying the affected products immediately and remove from the shelves within your pharmacy/store. Quarantine all remaining stock and return these to your supplier using your supplier's approved process.
  • Patients who have been supplied this batch of Clexane 4,000IU (40mg)/0.4ml Syringes should be informed that the error is only with the labelling on the plastic blister packaging encasing the syringe.
Full details of the dug 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 contractors.
GP Practices: Please note this alert is for Dispensing GP Practices only.


Alert reference: EL (20)A/37

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency