Eugia US LLC recalls Dexamethasone Sodium Phosphate injection vials with impurity sulfonic acid adducts above specifications. Affected vials have specific lot numbers and expiration dates. Contact for remedy details.
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Eugia US LLC is recalling certain Dexamethasone Sodium Phosphate injections due to impurities that could be harmful. This affects multiple-dose vials with specific lot numbers and expiration dates. The recall is for prescription-only use.
The vials contain impurity sulfonic acid adducts that exceed safety specifications. This could lead to harmful effects if the medication is administered. The exact risk level is not clearly described in the recall notice.
Prescription patients using the recalled Dexamethasone Sodium Phosphate injections. Healthcare providers who dispensed the affected vials are most at risk.
Check for lot numbers 3DS23001, 3DS23004 (expiring 6/30/2024) or 3DS23009, 3DS23011 (expiring 7/31/2024). The product is a prescription-only multiple-dose vial with 120mg per 30mL.
Identify the lot number and expiration date on the vial label to confirm if it is affected.
The recall states impurities exceed specifications, but the exact risk level is not clearly described. Do not use until confirmed safe.
The recall does not specify a remedy. Contact Eugia US LLC for guidance.
Look for lot numbers 3DS23001, 3DS23004 (expiring 6/30/2024) or 3DS23009, 3DS23011 (expiring 7/31/2024).
We’ve drafted a message you can send Eugia to request your refund or repair — edit it as you like.
Subject: Recall D-0555-2024 — Eugia Eugia Hello, I own a Eugia that is covered by recall D-0555-2024 from Eugia. 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.
