{
  "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": "Aiken",
      "state": "SC",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA022360"
        ],
        "brand_name": [
          "NICORETTE"
        ],
        "generic_name": [
          "NICOTINE POLACRILEX"
        ],
        "manufacturer_name": [
          "Haleon US Holdings LLC"
        ],
        "product_ndc": [
          "0135-0508",
          "0135-0509"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NICOTINE"
        ],
        "rxcui": [
          "359817",
          "359818",
          "968849",
          "968851"
        ],
        "spl_id": [
          "12f1fec8-003a-8788-e063-6394a90a298a"
        ],
        "spl_set_id": [
          "fdee1637-8049-4bc5-b196-b6d854c9f9f3"
        ],
        "package_ndc": [
          "0135-0508-02",
          "0135-0508-03",
          "0135-0508-04",
          "0135-0509-02",
          "0135-0509-03",
          "0135-0509-04"
        ],
        "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": "67800",
      "recalling_firm": "GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline",
      "address_1": "65 Windham Blvd",
      "address_2": "N/A",
      "postal_code": "29805-9384",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-1246-2014",
      "product_description": "Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland.  20 Count NDC: 0135-0509-04, 81 Count NDC: 0135-0509-02.",
      "product_quantity": "189,900 20 ct Vials, 145,068 81 ct Vials",
      "reason_for_recall": "Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.",
      "recall_initiation_date": "20140220",
      "center_classification_date": "20140418",
      "termination_date": "20170120",
      "report_date": "20140430",
      "code_info": "(20 ct) Lot #14337 (exp 7/15), 14398 (exp 9/15) & 14510 (exp 9/15); (81 ct) Lot #14336 (exp 7/15), 14347 (exp 7/15), 14378 (9/15), 14563 (exp 9/15)",
      "more_code_info": ""
    }
  ]
}