FDA Drug recall D-0555-2024
Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma…
- FDA Drug
- Class II
- ongoing
- Published 2024-06-26
On 2024-06-26 the FDA classified a Class II recall of Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma… by Eugia Us, citing failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0555-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-23 |
| Published | 2024-06-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Eugia Us |
| Distribution | US |
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
Reason
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Identifiers
| ndc | 55150-237-01 |
|---|---|
| ndc | 55150-238-05 |
| ndc | 55150-239-30 |
| code_info | Lot#: 3DS23001, 3DS23004, Exp 6/30/2024; 3DS23009, 3DS23011, Exp 7/31/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0555-2024%22
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