Company led medicines recall: Respreeza 1,000 mg powder and solvent for solution for infusion (EU/1/15/1006/001)

CSL Behring UK Ltd is recalling specific batches of Respreeza 1,000 mg powder and solvent for solution for infusion (EU/1/15/1006/001) due to a manufacturing deviation that occurred during the filling process.

CLDA Number

CLDA (21)A/02

MDR Number

MDR 178-01/21

Company Name

CSL Behring UK Ltd

Product description

Respreeza 1,000 mg powder and solvent for solution for infusion (EU/1/15/1006/001)

Lot Number/ Expiry

Batch Number Expiry Date First Distributed
P100043501 31 August 2021 29 December 2018
P100237408 31 August 2022 24 July 2020

Brief Description of Problem

CSL Behring UK Ltd is recalling the above batches of Respreeza 1,000 mg powder and solvent for solution for infusion (EU/1/15/1006/001) due to a manufacturing deviation that occurred during the filling process. There is a risk of potential microbial contamination due to the failure of the HEPA filters at the manufacturing site and the batches are being recalled as a precautionary measure.

This product is only supplied to Pharmacies and/or Hospitals Pharmacies and not to wholesale, via our 3PL partner Alloga UK Ltd.

Company Contact for medical information enquiries

For medical information enquiries, please contact: Jo Heaton (Head of Medical Affairs UK & Ireland, Commercial Operations United Kingdom) CSL Behring UK Ltd by emailing: Jo.Heaton@cslbehring.com

Company Contact for stock enquiries

For stock information enquiries, please contact: Karien Pietersen (Head of Quality) CSL Behring UK Ltd by emailing: Karien.pietersen@cslbehring.com

Published 20 January 2021