Ganciclovir Sodium, 250MG / NS 100ML, QTY: 6 100 mL Bags, Rx Only. Compounded by: United…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Recalling firm

Lincare, Inc.

Origin

AR, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-1204-2015

Other Ganciclovir recalls

See all

Class II · Moderate risk Terminated Dec 27, 2022

GANCICLOVIR ( CYTOVENE) (a)1480MG IN NS 296ML, (b) 740 MG IN NS 336 ML, antiviral, Rx Only, use with a Curlin pump, Sentara Home…

Reason Lack of sterility assurance

Sentara Infusion Services D-0294-2023

Class II · Moderate risk Terminated Dec 16, 2022

Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH…

Reason Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.

Hikma Pharmaceuticals USA Inc. NDC 0143-9299-01 D-0090-2023

Class II · Moderate risk Terminated Nov 4, 2019

Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for: Actavis…

Reason Presence of foreign substance: Brown/black particles found during stability testing.

Teva Pharmaceuticals USA, Inc. NDC 0591-2579-20 D-0518-2020

Class II · Moderate risk Terminated Feb 13, 2018

Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ…

Reason Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and…

Hetero Labs Limited Unit V NDC 31722-832-60 D-0601-2018

Class II · Moderate risk Terminated Sep 18, 2015

GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 488ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA…

Reason Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

Sentara Enterprises D-0626-2016