Cymevene 500 mg Powder for Infusion — Class II drug recall D-105-2013
Terminated recall by F. Hoffmann-LaRoche Ltd., reported 2013-01-02. Lack of Assurance of Sterility; container closure issues with the bulk batch.
| Recall number | D-105-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | F. Hoffmann-LaRoche Ltd., Basel, N/A, Switzerland |
| Recall initiated | 2012-09-05 |
| Classified | 2012-12-21 |
| Reported by FDA | 2013-01-02 |
| Terminated | 2013-08-29 |
| Countries outside the US | CH, KR |
| Quantity | 42,010 vials |
| Reason classes | sterility |
| Lot numbers | 2014, N0019, N0019B01-N0019B12 |
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 for recall
Lack of Assurance of Sterility; container closure issues with the bulk batch.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-105-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.