{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Shirley",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA021135"
        ],
        "brand_name": [
          "VENOFER"
        ],
        "generic_name": [
          "IRON SUCROSE"
        ],
        "manufacturer_name": [
          "Fresenius Medical Care Holdings, Inc."
        ],
        "product_ndc": [
          "49230-530",
          "49230-534"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "IRON SUCROSE"
        ],
        "rxcui": [
          "1741267",
          "1741268",
          "1741270",
          "1741271"
        ],
        "spl_id": [
          "e12cb876-ae80-416b-9bd3-a1cc83c9e666"
        ],
        "spl_set_id": [
          "f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040"
        ],
        "package_ndc": [
          "49230-530-01",
          "49230-530-10",
          "49230-530-25",
          "49230-534-01",
          "49230-534-10",
          "49230-534-25"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0349230530254",
          "0349230534252"
        ],
        "nui": [
          "M0011718",
          "N0000177913"
        ],
        "pharm_class_cs": [
          "Iron [CS]"
        ],
        "pharm_class_epc": [
          "Parenteral Iron Replacement [EPC]"
        ],
        "unii": [
          "FZ7NYF5N8L"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95711",
      "recalling_firm": "American Regent, Inc.",
      "address_1": "5 Ramsey Rd",
      "address_2": "",
      "postal_code": "11967-4701",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0081-2025",
      "product_description": "Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/vial cartons).",
      "product_quantity": "",
      "reason_for_recall": "Presence of Particulate Matter: Potential for glass delamination from the vials.",
      "recall_initiation_date": "20241111",
      "center_classification_date": "20241129",
      "report_date": "20241211",
      "code_info": "Lot #s: 4206, 4210, Exp 05/31/2026; 4223, Exp 06/30/2026; 24231, 24237, Exp 07/31/2026.",
      "more_code_info": ""
    }
  ]
}