Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of sterility assurance
GANCICLOVIR ( CYTOVENE) (a)1480MG IN NS 296ML, (b) 740 MG IN NS 336 ML, antiviral, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
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.
Reason Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Reason Presence of foreign substance: Brown/black particles found during stability testing.
Reason Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and…
Reason Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
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