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