Company led drug alert: Sodium chloride 0.9% Solution for injection (PL 08828/0178)
- The problem
- Fresenius Kabi Ltd is recalling the above batch of Sodium chloride 0.9% Solution for injection (PL 08828/0178) which has a polish labelled ampoule within some of the cartons. As this does not impact the full batch, as a precautionary measure Fresenius Kabi are recalling all…
- What to do
- Check the batch number on your pack against the list below. Do not stop taking a prescribed medicine without talking to your pharmacist, GP or prescriber first – they can check your supply and swap it if needed.
CLDA Number
CLDA (20)A/04
MDR Number
MDR 041-12/20
Company Name
Fresenius Kabi Ltd
Product Description
Sodium chloride
0.9% Solution for injection (PL 08828/0178)
Batch Number/Expiry
- Batch number: 20PEF024
- Expiry date: 04/2022
- Pack size: 50 x 10ml ampoules
- First distributed: 03 Dec 2020
Brief description of problem
Fresenius Kabi Ltd is recalling the above batch of Sodium chloride 0.9% Solution for injection (PL 08828/0178) which has a polish labelled ampoule within some of the cartons. As this does not impact the full batch, as a precautionary measure Fresenius Kabi are recalling all packs from this batch number.
The outer carton is correct and includes the correct patient information leaflet in the English language. The ampoules are the correct composition and specifications as the UK licensed material, however during manufacture the incorrect ampoule label was used.
The affected batch is being recalled and all stock will be replaced by corrected stock from Fresenius Kabi Limited.
Company Contact for medical information enquiries
For medical information enquiries, please contact: Fresenius Kabi Ltd
Email: medical.information-UK@fresenius-kabi.com
Company Contact for stock enquiries
Remaining stock of these batches should be quarantined and returned to Fresenius Kabi Limited for replacement stock.
For stock information enquiries, please contact: Fresenius Kabi Ltd customer services centre
Email: Customer.Services-UK@Fresenius-Kabi.com
Updated 18 December 2020. This page summarises an official notice. Details can change – always follow the official notice.