drugs Class II Updated 2013-01-02

F. Hoffmann-LaRoche Ltd. recalls Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL

Recalled 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

Hazard / Issue

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

Issued by

FDA

Distribution: No product distributed in the USA. Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea.
Lot/Code Info: bulk lot N0019, Expiration Date: 11 2014 Warennummer: 10131968 Chargennummer:NXXXX 2000609D Finished product Lot N0019B01-N0019B12
View official government recall

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