OPDIVO 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung (parallel distribution Haemato Pharm GmbH)
Recall
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Medicines
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05/04/2024
The parallel distributor and marketing authorisation holder informed its customers on March 28, 2024, that some vials have a defective closure of the crimp cap. The sterility cannot be guaranteed. Therefore, these batches are being recalled as a precautionary measure.
| Name of the medicinal product | OPDIVO 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung |
|---|---|
| Marketing authorisation number(s) | EU/1/15/1014/001-004-P1 |
| CIP code | 4473623 |
| Marketing authorisation holder | Haemato Pharm GmbH |
| Batch number(s) | 8053059_334914 8053062_405732 |
| Expiry date | 12/31/2025 |
| Classification of the recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-4705 |
Further inquiry note
Page last modified:
10/04/2024