IRON SUCROSE Recall D-0080-2025
Description: Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons).
IRON SUCROSE Recall D-0080-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0080-2025 |
| Event ID | 95711 |
| Brand | VENOFER |
| Generic Name | IRON SUCROSE |
| Manufacturer | IRON SUCROSE |
| Original Package? | 1 |
| Active Substance | IRON SUCROSE |
| Drug Route | INTRAVENOUS |
| Distribution | Nationwide in the USA |
| Recall Reason | Presence of Particulate Matter: Potential for glass delamination from the vials. |
| Drug Classification | Class II |
| Drug Code Info | 20241211 |
| Product NDC | 49230-530 49230-534 |
| Product NUI | M0011718 N0000177913 |
| Drug UPC | 0349230530254 0349230534252 |
| Pharma Class (EPC) | Parenteral Iron Replacement [EPC] |
| Pharma Class (CS) | Iron [CS] |
| Recall Initiation Date | 20241111 |
| Report Date | 20241211 |
| Classification Date | 20241129 |
| Address | 5 Ramsey Rd Shirley, NY 11967-4701 United States |
| Recalling Firm | American Regent, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | FZ7NYF5N8L |
| Drug Application Number | NDA021135 |
| Structured Product Labeling (SPL ID) | d169adb0-d1dc-4c19-99b4-f1dce90db380 |
| Structured Product Labeling (SPL Set ID) | f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040 |
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