CLDA Number: CLDA (20)A/04

MDR Number: MDR 041-12/20

Date Issued: 18th December 2020

Fresenius Kabi Ltd is recalling the below listed 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.

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

Advice for healthcare professionals

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