DOFETILIDE
Generic: DOFETILIDE
Aurobindo Pharma LimitedManufacturer
ORALRoute
DOFETILIDEActive Substance
2019-01-22Original Approval
DOFETILIDE is FDA application ANDA210740, sponsored by AUROBINDO PHARMA LTD. 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 II2023-02-07
Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27CGMP Deviations: recalling drug products following an FDA inspection.
Class III2023-07-18
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, SuOut of Specification result observed in content uniformity testing
Class II2023-02-07
Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27CGMP Deviations: recalling drug products following an FDA inspection.
Class II2023-02-07
Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NCCGMP Deviations: recalling drug products following an FDA inspection.
Top Reported Reactions
1
DRUG INEFFECTIVE
337 reports
2
ATRIAL FIBRILLATION
214 reports
3
DEATH
172 reports
4
ELECTROCARDIOGRAM QT PROLONGED
167 reports
5
DYSPNOEA
155 reports
6
DIZZINESS
122 reports
7
FATIGUE
121 reports
8
HEADACHE
87 reports
9
DIARRHOEA
85 reports
10
TORSADE DE POINTES
80 reports