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 II2024-02-13
Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal PharmaceuFailed Impurities/Degradation Specifications: Out-of-specification test results.
Class III2021-01-21
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurit
Class II2021-03-15
Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg oseltamivir base after constitution. 60 mL (uCGMP Deviations: Intermittent exposure to temperature excursion during storage.
Top Reported Reactions
1
OFF LABEL USE
1,864 reports
2
DRUG INEFFECTIVE
800 reports
3
NO ADVERSE EVENT
585 reports
4
VOMITING
489 reports
5
NAUSEA
485 reports
6
HEADACHE
433 reports
7
DRUG INTOLERANCE
408 reports
8
PNEUMONIA
389 reports
9
CONDITION AGGRAVATED
383 reports
10
PRODUCT USE IN UNAPPROVED INDICATION
351 reports