DEXAMETHASONE SODIUM PHOSPHATE Recall D-0555-2024
Description: 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
DEXAMETHASONE SODIUM PHOSPHATE Recall D-0555-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0555-2024 |
| Event ID | 94685 |
| Brand | DEXAMETHASONE SODIUM PHOSPHATE |
| Generic Name | DEXAMETHASONE SODIUM PHOSPHATE |
| Manufacturer | DEXAMETHASONE SODIUM PHOSPHATE |
| Original Package? | 1 |
| Active Substance | DEXAMETHASONE SODIUM PHOSPHATE |
| Drug Route | INTRA-ARTICULAR |
| Distribution | USA Nationwide |
| Quantity | 70,125 vials |
| Recall Reason | Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec. |
| Drug Classification | Class II |
| Drug Code Info | 20240626 |
| Product NDC | 55150-237 55150-238 55150-239 |
| Drug UPC | 0355150239306 0355150237012 0355150238057 |
| Recall Initiation Date | 20240523 |
| Report Date | 20240626 |
| Classification Date | 20240614 |
| Address | 279 Princeton Hightstown RdN/A East Windsor, NJ 08520-1401 United States |
| Recalling Firm | Eugia US LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | AI9376Y64P |
| Drug Application Number | ANDA206781 |
| Structured Product Labeling (SPL ID) | 34b1362a-f970-485f-bdac-3a02217157c9 |
| Structured Product Labeling (SPL Set ID) | ce7ad5a4-a9c5-42d6-87cc-ca16556208d2 |
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