{
  "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": [
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        ],
        "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": "71201",
      "recalling_firm": "Noven Pharmaceuticals, Inc.",
      "address_1": "11960 Sw 144th St",
      "address_2": "",
      "postal_code": "33186-6109",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1086-2015",
      "product_description": "Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufactured for Noven Therapeutics LLC, Miami, FL 33186, by Noven Pharmaceuticals Inc., Miami, FL 33186, NDC # 68968-5555-3",
      "product_quantity": "125,340 Patches",
      "reason_for_recall": "Defective Delivery System: One lot exceeded the mechanical peel specification",
      "recall_initiation_date": "20150112",
      "center_classification_date": "20150528",
      "termination_date": "20190319",
      "report_date": "20150603",
      "code_info": "Lot # 73346, Exp 03/2015",
      "more_code_info": ""
    }
  ]
}