Drug product
Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Welwyn Garden City, AL7 1TW, United Kingdom
D-105-2013
Product summary
- Event
- Event 63656
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42010 vials
- Official record key
drug-enforcement:D-105-2013
Official wording
Reason: Lack of Assurance of Sterility; container closure issues with the bulk batch.
Code information: bulk lot N0019, Expiration Date: 11 2014 Warennummer: 10131968 Chargennummer:NXXXX 2000609D Finished product Lot N0019B01-N0019B12
Distribution pattern: No product distributed in the USA. Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility