{
  "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": [
          "NDA209376"
        ],
        "brand_name": [
          "TRALEMENT"
        ],
        "generic_name": [
          "TRACE ELEMENTS INJECTION 4"
        ],
        "manufacturer_name": [
          "American Regent, Inc."
        ],
        "product_ndc": [
          "0517-9305"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ZINC SULFATE",
          "CUPRIC SULFATE",
          "MANGANESE SULFATE",
          "SELENIOUS ACID"
        ],
        "rxcui": [
          "2693627",
          "2693633"
        ],
        "spl_id": [
          "98253bed-5ff4-478f-aff5-c35944fad08a"
        ],
        "spl_set_id": [
          "a49ffb90-f307-433e-a86e-aaea6d6a9982"
        ],
        "package_ndc": [
          "0517-9305-01",
          "0517-9305-25"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0305178201250"
        ],
        "unii": [
          "89DS0H96TB",
          "LRX7AJ16DT",
          "W00LYS4T26",
          "F6A27P4Q4R"
        ]
      },
      "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-0801-2026",
      "product_description": "Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.",
      "product_quantity": "323,000 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 #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.",
      "more_code_info": ""
    }
  ]
}