D-105-2013 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 2, 2013
- Initiation Date
- September 5, 2012
- Termination Date
- August 29, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42010 vials
Product Description
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
Reason for Recall
Lack of Assurance of Sterility; container closure issues with the bulk batch.
Distribution Pattern
No product distributed in the USA. Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea.
Code Information
bulk lot N0019, Expiration Date: 11 2014 Warennummer: 10131968 Chargennummer:NXXXX 2000609D Finished product Lot N0019B01-N0019B12