Ganciclovir Injectable Solution Recalled Due to Lack of Sterility Assurance
Sentara Infusion Services is recalling Ganciclovir (Cytovene) injectable solutions due to lack of sterility assurance. The medication was dispensed to patients nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a parenteral (injectable) medication with sterility concerns. Although no illnesses or injuries are reported in the source material, injectable medications without sterility assurance represent a high-risk-of-harm product, meeting the rubric criterion for High severity.
Plain-English summary
Sentara Infusion Services is recalling Ganciclovir (Cytovene) injectable solutions in two concentrations: 1480 mg in 296 mL normal saline and 740 mg in 336 mL normal saline. The recalled product consists of 5 bags with a beyond-use date of December 24-29, 2022.
The recall is due to lack of sterility assurance in the product. Ganciclovir is an antiviral medication administered via infusion pump and is available by prescription only. Injectable medications must maintain strict sterility standards to prevent serious infections and systemic complications.
The medication was dispensed to patients nationwide through Sentara Home Infusion Pharmacy Services in Chesapeake, Virginia. Patients who received this medication should contact their healthcare provider or pharmacist immediately for guidance on their treatment and whether replacement medication is needed.
The recalled product
- Product
- 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
- Manufacturer
- Sentara Infusion Services
- Category
- Drug — Injectable Antiviral
- Hazard
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Beyond Use Date: December 24-29
- 2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 53 recalled by Sentara Infusion Services under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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