FDA DrugClass IINotable
FDA Recall: Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Via
Description
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
Hazard
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
Remedy
62190 vials
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