SUNITINIB MALATE
Generic: SUNITINIB MALATE
Aurobindo Pharma LimitedManufacturer
ORALRoute
SUNITINIB MALATEActive Substance
2024-03-14Original Approval
SUNITINIB MALATE is FDA application ANDA218615, sponsored by EUGIA 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 II2023-07-05
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., ParsippaFailed Moisture Limits: Water (moisture) content above the approved product specifications.
Class II2024-10-18
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-90Labeling: Label Mix-Up
Class II2024-10-18
Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902Labeling: Label Mix-Up
Top Reported Reactions
1
DIARRHOEA
306 reports
2
DISEASE PROGRESSION
271 reports
3
DEATH
267 reports
4
FATIGUE
252 reports
5
VOMITING
249 reports
6
PLATELET COUNT DECREASED
238 reports
7
THROMBOCYTOPENIA
228 reports
8
NAUSEA
222 reports
9
ANAEMIA
201 reports
10
ASTHENIA
190 reports