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CSL Behring recalls specific batches of Respreeza

Pb Staff writer
By Pb Staff writerJan 22, 2021
Pb Staff writer
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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).

Product details

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 NumberExpiry DateFirst Distributed
P10004350131 August 202129 December 2018
P10023740831 August 202224 July 2020

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