Summary:

• CSL Behring cannot guarantee that the manufacturing of Respreeza (human alpha-1-proteinase inhibitor, powder and solvent for solution for infusion, 1.000 mg, 4.000 mg and 5.000 mg) met aseptic conditions during the filling operations of the vials at all times. As a precaution, the company is recalling affected batches.
• This recall is at hospital and pharmacy level. The list of affected product batches is attached to this communication as attachment 1.
• Pharmacies/hospitals are requested to immediately stop the use and the distribution of the affected product batches. Any remaining packages in stock of the affected product batches are to be returned to CSL Behring.
• The recall will be initiated on <date>.
• As a result of the recall supply will be limited in <country>.
• CSL Behring is prepared to provide supply required to serve the majority of patients with current prescriptions for Respreeza but foresees limitations to serve all patients with a prescription.
• Patients who currently use Respreeza may need to be switched to a licensed alternative treatment if available and deemed necessary by the HCP.  In some circumstances, patients may have to attend clinic for administration of the alternative therapy or home administration by an HCP may be organized, in line with alternative product information.