{
  "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": [
          "NDA021330"
        ],
        "brand_name": [
          "NICORETTE"
        ],
        "generic_name": [
          "NICOTINE POLACRILEX"
        ],
        "manufacturer_name": [
          "Haleon US Holdings LLC"
        ],
        "product_ndc": [
          "0135-0510",
          "0135-0511"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NICOTINE"
        ],
        "rxcui": [
          "359817",
          "359818",
          "968849",
          "968851"
        ],
        "spl_id": [
          "142b2250-8264-423f-e063-6394a90ab05b"
        ],
        "spl_set_id": [
          "991704ed-781a-489b-8b56-0b558e8fc385"
        ],
        "package_ndc": [
          "0135-0510-01",
          "0135-0510-06",
          "0135-0510-07",
          "0135-0511-01",
          "0135-0511-06",
          "0135-0511-07",
          "0135-0515-03",
          "30142-862-01",
          "0363-0209-01",
          "0363-0209-07"
        ],
        "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-1240-2014",
      "product_description": "Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108.  Made in Switzerland. 72 Count NDC: 0135-0511-01,108 Count NDC: 0135-0515-03, b. Nicotine Lozenge Kroger,  Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-862-01 and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0209-01, 108 Count NDC: 0363-0209-07.",
      "product_quantity": "603,696 72 Ct Vials, 191,040 108 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": "Labeled A) 72 Ct Vial: Lot # 13434 (exp 4/14), 13546 (exp 5/14), 13907 (exp 11/14), 14020 (exp 1/15), 14107 (exp 3/15), 14183 (exp 4/15), 14273 (exp 7/15), 14335 (exp 8/15), & 14421 (exp 9/15), 12F27N (exp 4/14), 12K01N (exp 5/14), 13A25N (exp 11/14) & 13C18N (exp 1/15); 108 Ct Vial, Lot # 13383 (exp 4/14), 13626 (exp 5/14), 13725 (exp 10/14), 13861 (exp 12/14), 13980 (exp 1/15), 13982 (exp 1/15), 14091 (exp 4/15), 14153 (exp 5/15), 14227 (exp 7/15), 14262 (exp 7/15), 14318 (exp 8/15), 14371 (exp 8/15) & 14458 (exp 10/15). Labeled B) 72 Ct Vial; Lot # 13924 (exp 12/14),13975 (exp 12/14),14434 (exp 10/15). Labeled C) 72 Ct Vials, Lot #13614 (exp 7/14), 13790 (exp 10/14), 13889 (exp 11/14) & 14018 (exp 12/14), Lot # 13683 (4/17) & 13862 (11/14), 108 Ct Vial, Lot #13726 (exp 10/14) & 13779 (exp 11/14).",
      "more_code_info": ""
    }
  ]
}