VALGANCICLOVIR HYDROCHLORIDE FOR ORAL
Generic: VALGANCICLOVIR HYDROCHLORIDE
Actavis PharmaManufacturer
ORALRoute
VALGANCICLOVIR HYDROCHLORIDEActive Substance
2016-07-18Original Approval
VALGANCICLOVIR HYDROCHLORIDE FOR ORAL is FDA application ANDA205220, sponsored by ACTAVIS LABS FL INC. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class II2019-11-04
Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for: ActaviPresence of foreign substance: Brown/black particles found during stability testing.
Class II2018-02-13
Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. PiscatawaTemperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were expos
Top Reported Reactions
1
OFF LABEL USE
2,334 reports
2
CYTOMEGALOVIRUS INFECTION
1,429 reports
3
DRUG INEFFECTIVE
1,389 reports
4
NEUTROPENIA
987 reports
5
LEUKOPENIA
776 reports
6
ACUTE KIDNEY INJURY
702 reports
7
CYTOMEGALOVIRUS VIRAEMIA
694 reports
8
PYREXIA
681 reports
9
DIARRHOEA
647 reports
10
DRUG RESISTANCE
640 reports