{
  "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": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Shirley",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA209379"
        ],
        "brand_name": [
          "SELENIOUS ACID"
        ],
        "generic_name": [
          "SELENIOUS ACID"
        ],
        "manufacturer_name": [
          "American Regent, Inc."
        ],
        "product_ndc": [
          "0517-6502",
          "0517-6560"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "SELENIUM"
        ],
        "rxcui": [
          "2176324",
          "2591522"
        ],
        "spl_id": [
          "4f6657ea-8dfd-4a74-8a36-9855ca7fd34a"
        ],
        "spl_set_id": [
          "49324999-50e3-43ed-a8dd-156d6dbedd9f"
        ],
        "package_ndc": [
          "0517-6560-01",
          "0517-6560-05",
          "0517-6502-01",
          "0517-6502-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0305176502106"
        ],
        "unii": [
          "H6241UJ22B"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99503",
      "recalling_firm": "American Regent, Inc.",
      "address_1": "5 Ramsay Rd",
      "address_2": "",
      "postal_code": "11967-4701",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide within the U.S",
      "recall_number": "D-0798-2026",
      "product_description": "Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose Vial (NDC 0517-6502-10), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.",
      "product_quantity": "41,680 vials",
      "reason_for_recall": "Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde",
      "recall_initiation_date": "20260724",
      "center_classification_date": "20260826",
      "report_date": "20260826",
      "code_info": "Lot #: 25090, Exp. Date 2/28/2027.",
      "more_code_info": ""
    }
  ]
}