GANCICLOVIR ( CYTOVENE) (a)1480MG IN NS 296ML, (b) 740 MG IN NS 336 ML, antiviral, Rx Only, use w...

FDA Recall #D-0294-2023 — Class II — December 27, 2022

Recall #D-0294-2023 Date: December 27, 2022 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

Lack of sterility assurance

Recalling Firm

Sentara Infusion Services — Chesapeake, VA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

5 bags

Distribution

Dispensed to Patients Nationwide.

Code Information

Beyond Use Date: December 24-29, 2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated