RESPREEZA® Alpha-1 Proteinase Inhibitor (Human) Update
The following is a statement from CSL Behring regarding RESPREEZA® in the European Union:
February 8, 2021 – As a precautionary measure, CSL Behring has instituted a recall of certain batches of RESPREEZA®, due to a manufacturing deviation that occurred during the filling process.
Based on extensive product testing and a thorough analysis of pharmacovigilance data available to us, we have determined that the potential safety risk for patients deriving from continued use of RESPREEZA® is low, though it cannot be fully excluded.
Our commitment to patient care continues to be a key priority and guiding principle and our goal is to manage supply so that patients experience minimal disruption. In this regard, we expect to begin resupplying product in the European Union countries throughout the month of February and the beginning of March.
Patients are encouraged to contact their pharmacy regarding their individual prescription and to contact their physician about their treatment plan. Patients with medical questions regarding the select lots can contact us through local, in-country CSL Behring websites.