OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION

Generic: OSELTAMIVIR PHOSPHATE

Oryza Pharmaceuticals Inc.Manufacturer
ORALRoute
OSELTAMIVIR PHOSPHATEActive Substance
2024-07-02Original Approval

OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSION is FDA application ANDA217303, sponsored by PHARMOBEDIENT. 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 II2021-03-15
Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg oseltamivir base after constitution. 60 mL (u

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Top Reported Reactions

1
OFF LABEL USE
309 reports
2
VOMITING
268 reports
3
NAUSEA
247 reports
4
ABDOMINAL PAIN
195 reports
5
ABDOMINAL DISTENSION
183 reports
6
DRUG INTOLERANCE
180 reports
7
CONSTIPATION
179 reports
8
APPENDICITIS
177 reports
9
ASCITES
177 reports
10
APPENDICOLITH
174 reports