Kyprolis 60 mg Pulver zur Herstellung einer Infusionslösung New

Quality defect | Medicines | 05/07/2024

The parallel distributor and marketing authorisation holder informed its customers on July 04, 2024, that some vials have a defective closure of the crimp cap. The sterility cannot be guaranteed. Therefore, this batch is being recalled as a precautionary measure.  The possible defect is limited to this batch.

Name of the medicinal product Kyprolis 60 mg Pulver zur Herstellung einer Infusionslösung
Marketing authorisation number(s) EU/1/15/1060/001-P2
CIP code 4974957
Marketing authorisation holder Haemato Pharm GmbH
Batch number(s) 1169751A
Expiry date 07/31/2026
Classification of the recall1
Depth of recall Pharmacies
BASG reference number INS-640.001-4823
Email

Further inquiry note