F. Hoffmann-LaRoche Ltd. recalls Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Pr
Recalled January 2, 2013 · FDA recall D-105-2013 · F. Hoffmann-LaRoche
Hazard
Lack of Assurance of Sterility; container closure issues with the bulk batch. · FDA Class II
Units
42010 vials
Sold at
No product distributed in the USA. Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea.
Description
Lack of Assurance of Sterility; container closure issues with the bulk batch.
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
Manufacturer(s)
F. Hoffmann-LaRoche Ltd.
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →