{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Miramar",
      "state": "FL",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA074612"
        ],
        "brand_name": [
          "NICOTINE"
        ],
        "generic_name": [
          "NICOTINE"
        ],
        "manufacturer_name": [
          "Rugby Laboratories"
        ],
        "product_ndc": [
          "0536-5894",
          "0536-5896",
          "0536-5895"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TRANSDERMAL"
        ],
        "substance_name": [
          "NICOTINE"
        ],
        "rxcui": [
          "198029",
          "198030",
          "198031"
        ],
        "spl_id": [
          "1a266044-8837-71cc-e063-6394a90afcc0"
        ],
        "spl_set_id": [
          "2dd4cbda-5c46-4655-b69d-21b7d2e912cf"
        ],
        "package_ndc": [
          "0536-5896-53",
          "0536-5896-88",
          "0536-5896-71",
          "0536-5895-53",
          "0536-5895-88",
          "0536-5895-71",
          "0536-5894-53",
          "0536-5894-88"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175706",
          "M0014836"
        ],
        "pharm_class_epc": [
          "Cholinergic Nicotinic Agonist [EPC]"
        ],
        "pharm_class_cs": [
          "Nicotine [CS]"
        ],
        "unii": [
          "6M3C89ZY6R"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98972",
      "recalling_firm": "AVEVA Drug Delivery Systems, Inc.",
      "address_1": "3250 Commerce Pkwy",
      "address_2": "",
      "postal_code": "33025-3907",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the U.S",
      "recall_number": "D-0550-2026",
      "product_description": "Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.",
      "product_quantity": "59,808 pouches (4,272 Individual Folding Carton (IFC))",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.",
      "recall_initiation_date": "20260514",
      "center_classification_date": "20260526",
      "report_date": "20260603",
      "code_info": "Lot #: 56841, Expires: 03/2028",
      "more_code_info": ""
    }
  ]
}