FDA-Drug2013-01-02Class II
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
F. Hoffmann-LaRoche Ltd.
Hazard
Lack of Assurance of Sterility; container closure issues with the bulk batch.
Sold states
No product distributed in the USA. Bulk product distributed to Switzerland, with further distribution in Europe, Scandinavia, Korea.
Affected count
42010 vials
Manufactured in
Grenzacherstrasse 124, N/A, Basel, N/A, Switzerland
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-105-2013Don't want to check this manually?
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