{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "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": [
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        "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": "90506",
      "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": "Distributed Nationwide in the USA",
      "recall_number": "D-1169-2022",
      "product_description": "Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5552-3",
      "product_quantity": "8,559 cartons",
      "reason_for_recall": "Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.",
      "recall_initiation_date": "20220624",
      "center_classification_date": "20220629",
      "report_date": "20220706",
      "code_info": "Lot: 91272 Exp. 12/22.",
      "more_code_info": ""
    }
  ]
}