Dexamethasone Sodium Phosphate injection USP recall
FDA recall D-0555-2024 · initiated May 23, 2024
Eugia US LLC recalled Dexamethasone Sodium Phosphate injection USP in May 2024 — an FDA Class II recall (D-0555-2024) because Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 70,125 vials
Details
- Product
- Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, Made in India, NDC 55150-239-30
- Recalling company
- Eugia Pharma
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- May 23, 2024
- FDA report date
- Jun 26, 2024
Frequently asked
- Was Dexamethasone Sodium Phosphate injection USP recalled?
- Eugia US LLC recalled Dexamethasone Sodium Phosphate injection USP in May 2024 — an FDA Class II recall (D-0555-2024) because Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Dexamethasone Sodium Phosphate injection USP recalled?
- Per the FDA enforcement record, the reason for recall D-0555-2024 was: Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
- Is a recalled Dexamethasone Sodium Phosphate injection USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Dexamethasone Sodium Phosphate injection USP are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot#: 3DS23001, 3DS23004, Exp 6/30/2024; 3DS23009, 3DS23011, Exp 7/31/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0555-2024.