DEXAMETHASONE SODIUM PHOSPHATE

Generic: DEXAMETHASONE SODIUM PHOSPHATE

Amneal Pharmaceuticals LLCManufacturer
INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUERoute
DEXAMETHASONE SODIUM PHOSPHATEActive Substance
2018-08-22Original Approval

DEXAMETHASONE SODIUM PHOSPHATE is FDA application ANDA208689, sponsored by AMNEAL. 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 s

Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone ad

Class III2019-10-17
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured b

Labeling: Incorrect or missing package insert.

Class II2024-05-23
Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by

Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phospha

Class II2025-08-13
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manuf

Temperature Abuse

Class II2022-04-13
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, 3.5 g tube, Rx only MFG: Sandoz, NDC 61314-631-

cGMP deviations: Temperature abuse

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 m

Failed 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, Manufac

Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stabi

Top Reported Reactions

1
OFF LABEL USE
23,122 reports
2
FATIGUE
17,595 reports
3
DIARRHOEA
17,472 reports
4
NAUSEA
14,512 reports
5
PLASMA CELL MYELOMA
14,349 reports
6
PNEUMONIA
14,039 reports
7
DEATH
13,528 reports
8
DRUG INEFFECTIVE
13,385 reports
9
NEUTROPENIA
11,916 reports
10
PYREXIA
11,509 reports