Somerset Therapeutics recalls 10x10mL Dexamethasone Sodium Phosphate injection vials due to impurities detected during stability testing. These impurities could pose health risks if used beyond expiry.
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.
Somerset Therapeutics is recalling 10x10 mL Dexamethasone Sodium Phosphate injection vials because impurities were found during long-term stability testing. These impurities could potentially cause health risks if the medication is used after the expiry date.
The medication contained impurities (Dexamethasone Sodium Phosphate EP impurity G and dexamethasone formate) that were above acceptable levels during long-term stability testing. These impurities could potentially cause health risks if the medication is used after the expiry date.
Prescription patients who received this specific Dexamethasone injection vial. Patients using the medication for conditions like inflammation or autoimmune disorders are most at risk.
Check for the product name 'Dexamethasone Sodium Phosphate Injection, USP, 100 mg/10 mL (10 mg/mL), 10x10 mL Multiple Dose Vials' with NDC carton number 70069-025-10 and vial number 70069-025-01. The lot number is A240421 with an expiration date of 07/31/2026.
Identify the NDC carton number 70069-025-10 and vial number 70069-025-01 on the packaging.
The recall is due to impurities detected during stability testing, but the product is safe to use if stored properly and used before the expiration date.
The recall does not specify a remedy, so contact your healthcare provider for advice on whether to continue using the product.
Look for the NDC carton number 70069-025-10 and vial number 70069-025-01 on the packaging, with lot number A240421 and expiration date 07/31/2026.
We’ve drafted a message you can send Somerset Therapeutics to request your refund or repair — edit it as you like.
Subject: Recall D-0398-2026 — Somerset Therapeutics Somerset Therapeutics Hello, I own a Somerset Therapeutics that is covered by recall D-0398-2026 from Somerset Therapeutics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
