Alert

Company led medicines recall: Glucose 10%w/v 10ml injection (unlicensed medicine) and Trometamol 7%w/v injection 5mL (unlicensed medicine)

East Suffolk and North Essex NHS Foundation Trust (MS 12882) is recalling specific batches of Glucose 10%w/v injection 10mL and Trometamol 7%w/v injection 5mL due to limited assurance of product sterility.

MDR Number MDR 401-09/21

Company name East Suffolk and North Essex NHS Foundation Trust (MS 12882)

Product description

Glucose 10%w/v 10ml injection (unlicensed medicine)

Trometamol 7%w/v injection 5mL (unlicensed medicine)

Details of the affected batches:

Product name

Batch Number

Expiry Date

Pack Size

First Distributed

Glucose 10%w/v injection 10ml

M02503

04/02/2023

5 x 10 ml

17 March 2021

Trometamol 7%w/v injection 5ml

M04506

27/04/2022

10 x 5 ml

21 June 2021

Brief description of problem

East Suffolk and North Essex NHS Foundation Trust (MS 12882) is recalling the above batches of Glucose 10%w/v injection 10mL and Trometamol 7%w/v injection 5mL. The batches are being recalled as a precautionary measure due to limited assurance of product sterility.

Oxford Pharmacy Store should be contacted to arrange for return and credit of affected stock. The affected stock should be quarantined when replacement stock is available to users.

This recall is being issued as a company-led medicines recall, as this product is only supplied to several hospital pharmacies and the manufacturer has full traceability of the onward distribution by their customers.

 Company contacts for further information

For medical information enquiries, please contact East Suffolk and North Essex NHS Foundation Trust Pharmacy Manufacturing Unit by emailing: pharmacy.manufacture@esneft.nhs.uk or telephone: 01473 703440

For stock information enquiries, Oxford Pharmacy Store, by emailing: ops.orders@oxfordhealth.nhs.uk or telephone: 01865 904141