{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Northfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M021"
        ],
        "brand_name": [
          "SPARKLEFRESH"
        ],
        "generic_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "manufacturer_name": [
          "Medline Industries, LP"
        ],
        "product_ndc": [
          "53329-083"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "SODIUM MONOFLUOROPHOSPHATE"
        ],
        "rxcui": [
          "545626"
        ],
        "spl_id": [
          "27d69435-782e-9b40-e063-6394a90a93f4"
        ],
        "spl_set_id": [
          "1565528b-89f2-4c97-b294-15b6ebd3f80e"
        ],
        "package_ndc": [
          "53329-083-21",
          "53329-083-92",
          "53329-083-93",
          "53329-083-94",
          "53329-081-93"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "C810JCZ56Q"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81381",
      "recalling_firm": "Medline Industries Inc",
      "address_1": "Three Lakes Drive",
      "address_2": "",
      "postal_code": "60093",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide USA and Puerto Rico",
      "recall_number": "D-0247-2019",
      "product_description": "SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (NDC 53329-083-93, product number NONTP85I), c) 42.5 g (NDC 53329-083-21, product number NONTP15I), d) 24 g tube (NDC 53329-081-93, product number DGN1000), Made in Malaysia for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA",
      "product_quantity": "994,756 tubes",
      "reason_for_recall": "Microbial Contamination of Non-Sterile Product",
      "recall_initiation_date": "20180917",
      "center_classification_date": "20181115",
      "termination_date": "20200904",
      "report_date": "20181114",
      "code_info": "a) Lot 102920C, exp 10/29/2020 and 111220C, exp 11/11/2020; b) 111620D, exp 11/16/2020; c) 111420D, exp 11/14/2020;  d) 111720C, exp 11/17/2020",
      "more_code_info": ""
    }
  ]
}