{
  "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 III",
      "openfda": {
        "application_number": [
          "ANDA203167"
        ],
        "brand_name": [
          "CLONIDINE"
        ],
        "generic_name": [
          "CLONIDINE"
        ],
        "manufacturer_name": [
          "XGen Pharmaceuticals DJB, Inc."
        ],
        "product_ndc": [
          "39822-2000",
          "39822-2010"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "EPIDURAL"
        ],
        "substance_name": [
          "CLONIDINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "884221",
          "884225"
        ],
        "spl_id": [
          "103027a7-2f0d-8d8c-e063-6294a90aedc7"
        ],
        "spl_set_id": [
          "ada02f1f-ae78-4435-879e-492ae862d504"
        ],
        "package_ndc": [
          "39822-2000-1",
          "39822-2010-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "W76I6XXF06"
        ]
      },
      "product_type": "Drugs",
      "event_id": "68729",
      "recalling_firm": "X-Gen Pharmaceuticals Inc.",
      "address_1": "300 Daniel Zenker Drive",
      "address_2": "",
      "postal_code": "14845-1014",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1444-2014",
      "product_description": "Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY  14814, NDC 39822-2000-1.",
      "product_quantity": "8,356 vials",
      "reason_for_recall": "Labeling: Label Error On Declared Strength: The side label description incorrectly states \"Each mL contains 500 mcg Clonidine Hydrochloride\" instead of stating \"Each mL contains 100 mcg Clonidine Hydrochloride\".",
      "recall_initiation_date": "20140717",
      "center_classification_date": "20140718",
      "termination_date": "20151007",
      "report_date": "20140730",
      "code_info": "Lot: PLNB1412, Exp 12/15",
      "more_code_info": ""
    }
  ]
}