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.
CLMR Number
CLMR (21)A/06
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)
Lot Number/Expiry
| 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 Contact for medical information enquiries
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
Company Contact for stock enquiries
For stock information enquiries, Oxford Pharmacy Store, by emailing: ops.orders@oxfordhealth.nhs.uk or telephone: 01865 904141