Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Medicine |
| Medsafe Reference: | 20421 |
| Brand Name: | Kogenate FS |
| Dose Form/Strength: | Injection with diluent 250 IU |
| Affected: | 270P95K |
| Recalling Organisation: | Bayer New Zealand Limited Consumer Health B:Hive Building 74 Tahoroto Rahoto, Takapuna Auckland 0622 |
| Contact Information: | 0800 804 545 |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG |
| Brand Name: | Kogenate FS |
| Dose Form/Strength: | Injection with diluent 500 IU |
| Affected: | 270P95K |
| Recalling Organisation: | Bayer New Zealand Limited Consumer Health B:Hive Building 74 Tahoroto Rahoto, Takapuna Auckland 0622 |
| Contact Information: | 0800 804 545 |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG |
| Brand Name: | Kogenate FS |
| Dose Form/Strength: | Injection with diluent 1000 IU |
| Affected: | 270P95K |
| Recalling Organisation: | Bayer New Zealand Limited Consumer Health B:Hive Building 74 Tahoroto Rahoto, Takapuna Auckland 0622 |
| Contact Information: | 0800 804 545 |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG |
| Brand Name: | Kogenate FS |
| Dose Form/Strength: | Injection with diluent 2000 IU |
| Affected: | 270P95K |
| Recalling Organisation: | Bayer New Zealand Limited Consumer Health B:Hive Building 74 Tahoroto Rahoto, Takapuna Auckland 0622 |
| Contact Information: | 0800 804 545 |
| Manufacturer: | Bayer Healthcare LLC |
| Brand Name: | Kogenate FS |
| Dose Form/Strength: | Powder for injection 3000 IU |
| Affected: | 270P95K |
| Recalling Organisation: | Bayer New Zealand Limited Consumer Health B:Hive Building 74 Tahoroto Rahoto, Takapuna Auckland 0622 |
| Contact Information: | 0800 804 545 |
| Manufacturer: | Vetter Pharma-Fertigung GmbH & Co KG |
| Issue: | Out of trend and out of specification stability results observed in some batches of finished product for Kogenate FS octocog alfa that were placed on stability study |
| Recall action type: | Recall |
| Recall action: | Recall |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 29/8/2016 |
