{
  "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": "Miami",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA021514"
        ],
        "brand_name": [
          "DAYTRANA"
        ],
        "generic_name": [
          "METHYLPHENIDATE"
        ],
        "manufacturer_name": [
          "Noven Therapeutics, LLC"
        ],
        "product_ndc": [
          "68968-5552",
          "68968-5553",
          "68968-5554",
          "68968-5555"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TRANSDERMAL"
        ],
        "substance_name": [
          "METHYLPHENIDATE"
        ],
        "rxcui": [
          "753436",
          "753437",
          "753438",
          "753439",
          "753440",
          "753441",
          "753442",
          "753443"
        ],
        "spl_id": [
          "55f4b5f4-6d3c-4677-a94c-d47ffb59a91a"
        ],
        "spl_set_id": [
          "2c312c31-3198-4775-91ab-294e0b4b9e7f"
        ],
        "package_ndc": [
          "68968-5552-3",
          "68968-5553-3",
          "68968-5554-3",
          "68968-5555-3"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175739",
          "N0000175729"
        ],
        "pharm_class_epc": [
          "Central Nervous System Stimulant [EPC]"
        ],
        "pharm_class_pe": [
          "Central Nervous System Stimulation [PE]"
        ],
        "unii": [
          "207ZZ9QZ49"
        ]
      },
      "product_type": "Drugs",
      "event_id": "69277",
      "recalling_firm": "Noven Pharmaceuticals, Inc.",
      "address_1": "11960 Sw 144th St",
      "address_2": "N/A",
      "postal_code": "33186-6109",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide.",
      "recall_number": "D-1608-2014",
      "product_description": "Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186.  NDC 68968-5554-3.",
      "product_quantity": "160,800 patches",
      "reason_for_recall": "Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.",
      "recall_initiation_date": "20140715",
      "center_classification_date": "20140923",
      "termination_date": "20190319",
      "report_date": "20141001",
      "code_info": "Lot # 71165; Exp. 12/14"
    }
  ]
}