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Originator: MHRA Drug Alerts

From: Himal Makwana

Issue date: 28-May-2020 10:59:17

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
  • NHS Trusts (England) - Chief Executive
  • GP - Locum
  • NHS 111 and Out of hours providers
  • Dispensing GP Practices
  • GP Practices
  • DHSC Supply Disruption - Medicines
  • Primary Care Networks

Action category: Class 4: For information

Title: CLASS 4 DRUG ALERT, FOR INFORMATION, TORBAY PHARMACEUTICALS (FOR VERITON PHARMA LTD), SODIUM BENZOATE (AMZOATE) 2G IN 10ML STERILE SOLUTION FOR INJECTION (UNLICENSED)

Broadcast content:

Torbay Pharmaceuticals has informed us that the carton label on Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection incorrectly states the concentration of disodium edetate (excipient) as 0.1% w/v (10mg in 1mL) instead of 0.1% w/v (10mg in 10mL). It should be noted that this product is manufactured as an unlicensed special.

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 Regional Offices: Please cascade this alert to Community Pharmacy and any Dispensing GP Practices yet to be registered with CAS.
GP Practices: Please note this alert is for Dispensing GP Practices only.


Alert reference: EL (20)A/24

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


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency