Company led 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.

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

Details of affected batch

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 contacts for further information

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

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