United StatesDexamethasone Sodium Phosphate Injection, USP 100 mg/10 mL (10 mg/mL) multiple-dose vials, 10x10 mL, Rx only, manufactured for Somerset Therapeutics LLC (NDC carton 70069-025-10; NDC vial 70069-025-01), Lot A240421, exp. 07/31/2026, distributed nationwide in the U.S. was recalled. The product was recalled because out-of-specification impurities were observed during long-term stability testing at product expiry, specifically EP impurity G (Impurity RU 49336) and dexamethasone formate.
What's being recalled
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 70069-025-01
Recalling firm: Somerset Therapeutics LLC, Somerset, NJ, United States.
How to identify it
Lot #: A240421, Exp 07/31/2026
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the USA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)