Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only...
FDA Recall #D-105-2013 — Class II — September 5, 2012
Product Description
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.
Recalling Firm
F. Hoffmann-LaRoche Ltd. — Basel, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
42010 vials
Distribution
No product distributed in the USA. Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea.
Code Information
bulk lot N0019, Expiration Date: 11 2014 Warennummer: 10131968 Chargennummer:NXXXX 2000609D Finished product Lot N0019B01-N0019B12
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated