Somerset Therapeutics dexamethasone injection recalled for impurity levels
Somerset Therapeutics is recalling one lot of dexamethasone sodium phosphate injection because testing found impurity levels above acceptable limits as the product approached its expiration date. The affected lot (A240421, expiring 07/31/2026) was distributed nationwide. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Check your facility's inventory for lot A240421 of Somerset Therapeutics dexamethasone sodium phosphate injection (NDC 70069-025-01 or 70069-025-10)
- Do not use vials from this lot
- Contact Somerset Therapeutics or your supplier for return or disposal instructions
- Consult your pharmacist or healthcare provider if you have questions
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 62190 vials
- Illnesses reported
- None reported
- Manufactured in
- 300 Franklin Square Dr, N/A, Somerset, NJ, United States
- Classification
- Class II
- Recall number
- D-0398-2026
In the FDA's words
- Description
- 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 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. Lot #: A240421, Exp 07/31/2026 Distribution: Nationwide in the USA Affected quantity: 62190 vials
- 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.