{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Horseheads",
      "state": "NY",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA202402"
        ],
        "brand_name": [
          "IBUPROFEN LYSINE"
        ],
        "generic_name": [
          "IBUPROFEN LYSINE"
        ],
        "manufacturer_name": [
          "XGen Pharmaceuticals DJB, Inc."
        ],
        "product_ndc": [
          "39822-1030"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "IBUPROFEN LYSINE"
        ],
        "rxcui": [
          "1747294"
        ],
        "spl_id": [
          "09c10e65-0cea-3052-e063-6394a90ae199"
        ],
        "spl_set_id": [
          "6cfdec66-9483-4abe-98d3-3a7d389cc952"
        ],
        "package_ndc": [
          "39822-1030-1",
          "39822-1030-2"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "N01ORX9D6S"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76410",
      "recalling_firm": "X-Gen Pharmaceuticals Inc.",
      "address_1": "300 Daniel Zenker Dr",
      "address_2": "N/A",
      "postal_code": "14845-1014",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0637-2017",
      "product_description": "Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single-Dose Vials per carton (NDC 39822-1030-2); Rx only, Distributed by: X-Gen Pharmaceuticals, Inc., Big Flats, NY 14814; Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.",
      "product_quantity": "2593 cartons",
      "reason_for_recall": "Presence of Particulate Matter",
      "recall_initiation_date": "20170208",
      "center_classification_date": "20170405",
      "termination_date": "20200610",
      "report_date": "20170412",
      "code_info": "PLND1613, Exp 02/18"
    }
  ]
}