FONDAPARINUX SODIUM

Generic: FONDAPARINUX SODIUM

Sandoz Inc.Manufacturer
SUBCUTANEOUSRoute
FONDAPARINUX SODIUMActive Substance
2018-05-15Original Approval

FONDAPARINUX SODIUM is FDA application ANDA206812, sponsored by HENGRUI 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 II2022-09-30
Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma

Subpotent Drug: Out of specification for assay

Top Reported Reactions

1
THROMBOSIS
41 reports
2
DRUG INEFFECTIVE
40 reports
3
HEPARIN-INDUCED THROMBOCYTOPENIA
39 reports
4
OFF LABEL USE
39 reports
5
PULMONARY EMBOLISM
39 reports
6
DIARRHOEA
34 reports
7
HAEMOGLOBIN DECREASED
33 reports
8
ABDOMINAL PAIN
31 reports
9
ANAEMIA
30 reports
10
DEEP VEIN THROMBOSIS
29 reports