{
  "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": "2026-03-18",
    "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": "82504",
      "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": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-1084-2019",
      "product_description": "Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1.",
      "product_quantity": "24,966 vials",
      "reason_for_recall": "Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as \"500 mcg Clonidine Hydrochloride\" rather than the correct concentration of \"100 mcg Clonidine Hydrochloride\" per mL.",
      "recall_initiation_date": "20190329",
      "center_classification_date": "20190408",
      "termination_date": "20210602",
      "report_date": "20190417",
      "code_info": "Lots #:  PMXA1917, Exp 09/2020; PMXA1937, PMXA1938, Exp 11/2020;"
    }
  ]
}