DEXAMETHASONE SODIUM PHOSPHATE
Generic: DEXAMETHASONE SODIUM PHOSPHATE
Fresenius Kabi USAManufacturer
INTRAMUSCULAR, INTRAVENOUSRoute
DEXAMETHASONE SODIUM PHOSPHATEActive Substance
2005-04-22Original Approval
DEXAMETHASONE SODIUM PHOSPHATE is FDA application ANDA040572, sponsored by FRESENIUS KABI USA. 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 III2017-11-06
Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per sFailed Impurities/Degradation Specifications: high out of specification results for Dexamethasone ad
Class II2024-05-23
Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed byFailed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phospha
Class III2017-11-06
Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 mFailed Impurities/Degradation Specifications: high out of specification results for Dexamethasone ad
Class II2026-02-04
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, ManufacFailed Impurities/Degradation Specifications - OOS impurities result observed during long term stabi
Top Reported Reactions
1
OFF LABEL USE
943 reports
2
NAUSEA
604 reports
3
PYREXIA
604 reports
4
ANAEMIA
496 reports
5
DRUG INEFFECTIVE
475 reports
6
DIARRHOEA
470 reports
7
PLATELET COUNT DECREASED
448 reports
8
MYELOSUPPRESSION
440 reports
9
NEUTROPHIL COUNT DECREASED
439 reports
10
WHITE BLOOD CELL COUNT DECREASED
438 reports