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

Recall Number: D-105-2013

Firm: F. Hoffmann-LaRoche Ltd.

Classification: Class II

Status: Terminated

Report Date: 20130102

Initiation Date: 20120905

Termination Date: 20130829

Lack of Assurance of Sterility; container closure issues with the bulk batch.

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