# FDA recall D-105-2013

> **F. Hoffmann-LaRoche Ltd.** · Class II · drug recall initiated 2012-09-05.

## 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.

## Distribution

No product distributed in the USA.  Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea.

## Key facts

- **Recall number:** D-105-2013
- **Recalling firm:** F. Hoffmann-LaRoche Ltd.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-09-05
- **Report date:** 2013-01-02
- **Termination date:** 2013-08-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Basel, N/A, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-105-2013

## Citation

> AI Analytics. FDA recall D-105-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-105-2013. Source: US FDA. Licensed CC0.

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