FDA Drug recall D-105-2013
Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Wel…
- FDA Drug
- Class II
- terminated
- Published 2013-01-02
On 2013-01-02 the FDA classified a Class II recall of Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Wel… by F Hoffmann Laroche, citing lack of Assurance of Sterility; container closure issues with the bulk batch.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-105-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-05 |
| Published | 2013-01-02 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | F Hoffmann Laroche |
| Distribution | n/a |
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
Reason
Lack of Assurance of Sterility; container closure issues with the bulk batch.
Identifiers
| code_info | bulk lot N0019, Expiration Date: 11 2014 Warennummer: 10131968 Chargennummer:NXXXX 2000609D Finished product Lot N0019B01-N0019B12 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-105-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.