Class II · Moderate risk Terminated
Ganciclovir
Reason Lack of sterility assurance
Cymevene 500 mg Powder for Infusion
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; container closure issues with the bulk batch.
What was recalled
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
- Recalling firm
- F. Hoffmann-LaRoche Ltd.
- Origin
- N/A, Switzerland
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-105-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Ganciclovir recalls
See all
Class II · Moderate risk Terminated
Ganciclovir for Injection
Reason Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Class II · Moderate risk Terminated
Valganciclovir Hydrochloride for Oral Solution
Reason Presence of foreign substance: Brown/black particles found during stability testing.
Class II · Moderate risk Terminated
Valganciclovir Tablets
Reason Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
Class II · Moderate risk Terminated
GANCICLOVIR in NS
Reason Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
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