FOSPHENYTOIN SODIUM
Generic: FOSPHENYTOIN SODIUM
Sagent PharmaceuticalsManufacturer
INTRAMUSCULAR, INTRAVENOUSRoute
FOSPHENYTOIN SODIUMActive Substance
2023-10-13Original Approval
FOSPHENYTOIN SODIUM is FDA application ANDA214926, sponsored by GLAND. 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 II2012-04-13
Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count Presence of Particulate Matter: This product is being recalled due to the discovery of particles in
Class II2012-04-13
Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x Presence of Particulate Matter: This product is being recalled due to the discovery of particles in
Top Reported Reactions
1
DRUG INEFFECTIVE
120 reports
2
OFF LABEL USE
70 reports
3
STATUS EPILEPTICUS
46 reports
4
CARDIAC ARREST
42 reports
5
HYPOTENSION
38 reports
6
PYREXIA
35 reports
7
SEIZURE
32 reports
8
BLOOD PRESSURE DECREASED
26 reports
9
DRUG INTERACTION
23 reports
10
RESPIRATORY DEPRESSION
23 reports