Reported Jan 2, 2013 · Terminated
Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche…
F. Hoffmann-LaRoche Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: F. Hoffmann-LaRoche Ltd. · Grenzacherstrasse 124 · Basel, N/A · N/A
Is this the product you have?
- 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
- Lot codes and dates
- bulk lot N0019
- Expiration Date11 2014
- Warennummer10131968
- ChargennummerNXXXX 2000609D Finished product Lot N0019B01-N0019B12
- Amount recalled
- 42010 vials
Why it was recalled
Lack of Assurance of Sterility; container closure issues with the bulk batch.
This product could cause temporary or reversible health problems — stop using it.
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