Status
Terminated
Drug Enforcement D-105-2013
Lack of Assurance of Sterility; container closure issues with the bulk batch.
Classification
Class II
Report Date
January 2, 2013
Termination Date
August 29, 2013
Product Information
- 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
- Product quantity
- 42010 vials
- Reason for recall
- Lack of Assurance of Sterility; container closure issues with the bulk batch.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- No product distributed in the USA. Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea.
Location & Firm
- Recalling firm
- F. Hoffmann-LaRoche Ltd.
- Address
-
Grenzacherstrasse 124, N/A
Switzerland - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-105-2013
- Event ID
- 63656
- Recall initiation date
- September 5, 2012
- Center classification date
- December 21, 2012
- Code info
- bulk lot N0019, Expiration Date: 11 2014 Warennummer: 10131968 Chargennummer:NXXXX 2000609D Finished product Lot N0019B01-N0019B12
- More code info
- —