CSL Behring UK Ltd has recalled specific batches of Respreeza 1,000 mg powder and solvent for solution for infusion due to a manufacturing deviation that occurred during the filling process.
The company says there is a risk of potential microbial contamination due to the failure of the HEPA filters at the manufacturing site and the affected 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,” the company has said in a communication to Medicines and Healthcare products Regulatory Agency (MHRA).
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)
|Batch Number||Expiry Date||First Distributed|
|P100043501||31 August 2021||29 December 2018|
|P100237408||31 August 2022||24 July 2020|