ENOXAPARIN SODIUM
Generic: ENOXAPARIN SODIUM
BluePoint LaboratoriesManufacturer
SUBCUTANEOUSRoute
ENOXAPARIN SODIUMActive Substance
2019-11-29Original Approval
ENOXAPARIN SODIUM is FDA application ANDA206834, sponsored by EMERGE BIOSCIENCE. 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 II2022-01-26
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous InjectionCGMP Deviations: Products were exposed to temperatures outside of the products labeled storage condi
Class II2025-08-05
Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefCorrect Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contain
Top Reported Reactions
1
OFF LABEL USE
1,026 reports
2
DYSPNOEA
979 reports
3
DIARRHOEA
934 reports
4
NAUSEA
934 reports
5
PYREXIA
889 reports
6
ANAEMIA
816 reports
7
VOMITING
786 reports
8
FATIGUE
738 reports
9
THROMBOCYTOPENIA
730 reports
10
PNEUMONIA
684 reports