Fresenius Kabi Ltd has recalled Sodium chloride 0.9% solution for injection following an incorrect use of ampoule label during the product manufacturing process.
The outer carton is correct and includes the correct patient information leaflet in English.
The ampoules are the correct composition and specifications as the UK licensed material, however during manufacture the incorrect ampoule label was used.
As a precautionary measure Fresenius Kabi has recalled all packs from this batch number.
Sodium chloride 0.9% Solution for injection with PL 08828/0178
Batch number: 20PEF024
Expiry date: 04/2022
Pack size: 50 x 10ml ampoules
First distributed: December 3, 2020
The affected batch is being recalled and all stock will be replaced by corrected stock from Fresenius Kabi Limited, the company has said in an advice to the healthcare professionals.
Community pharmacies have been advised to quarantine all remaining stock of these batches to return to Fresenius Kabi Limited for replacement stock.