DIGOXIN
Generic: DIGOXIN
Amici PharmaManufacturer
ORALRoute
DIGOXINActive Substance
2022-03-11Original Approval
DIGOXIN is FDA application ANDA215209, sponsored by AMICI PHARMA. 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 III2024-03-04
Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake DrivCross Contamination with Other Products:(mycophenolate mofetil).
Class III2024-03-25
Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake DriFailed Impurities/Degradation Specifications
Top Reported Reactions
1
DYSPNOEA
5,599 reports
2
NAUSEA
4,365 reports
3
DIZZINESS
4,140 reports
4
FATIGUE
3,895 reports
5
ATRIAL FIBRILLATION
3,625 reports
6
DIARRHOEA
3,470 reports
7
ASTHENIA
3,143 reports
8
VOMITING
3,074 reports
9
DEATH
3,041 reports
10
HYPOTENSION
2,902 reports