{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Orangeburg",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA021524"
        ],
        "brand_name": [
          "PREVANTICS SWABSTICK"
        ],
        "generic_name": [
          "CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL"
        ],
        "manufacturer_name": [
          "Professional Disposables International, Inc."
        ],
        "product_ndc": [
          "10819-4077"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CHLORHEXIDINE GLUCONATE",
          "ISOPROPYL ALCOHOL"
        ],
        "rxcui": [
          "1191171",
          "1366736"
        ],
        "spl_id": [
          "2dced465-11bf-7823-e063-6394a90a9fac"
        ],
        "spl_set_id": [
          "9841200b-d4c6-b40c-e053-2995a90a5596"
        ],
        "package_ndc": [
          "10819-4077-1",
          "10819-4077-4",
          "10819-4077-2",
          "10819-4077-3"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "MOR84MUD8E",
          "ND2M416302"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89547",
      "recalling_firm": "Professional Disposables International, Inc.",
      "address_1": "2 Nice Pak Park",
      "address_2": "",
      "postal_code": "10962-1317",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed nationwide in the USA and Puerto Rico.",
      "recall_number": "D-0572-2022",
      "product_description": "Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Swabstick, 0.054 fl. oz. (1.6 mL) Each in a pouch, NDC 10819-4077-1; 50 Individual Swabsticks per carton, 10 boxes of 50 Individual Swabsticks per case, REORDER NO. S40750, NDC 10819-4077-4; b) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S32450, NDC 10819-4077-2; c) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S42850, NDC 10819-4077-3; Professional Disposables International, Inc., Orangeburg, NY  10962-1376.",
      "product_quantity": "a) 28201 cases; b) 7579 cases; c) 8882 cases",
      "reason_for_recall": "cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.",
      "recall_initiation_date": "20220204",
      "center_classification_date": "20220218",
      "termination_date": "20231031",
      "report_date": "20220302",
      "code_info": "Lot #: a) 12000203, 12000204, Exp Mar 2022; 12001114 LE, Exp Jun 2022; 12001115 LE, 12001117 LE, Exp Jul 2022; 12001313, 12001407, 12001408, Exp Aug 2022; 12001498, 12001499, 12001500, 12001629, 12001630, Exp Sep 2022; 12002070, 12002114, Exp Dec 2022; 12100106, 12100107, 12100223, Exp Feb 2023; 12100224, 12100225, 12100354, 12100513, Exp Mar 2023; 12100514, 12100515, 12100605, 12100628, Exp Apr 2023; 12100629, 12100630, Exp May 2023; b) 12000332, Exp Feb 2022; 12000484, Exp Mar 2022; 12001116 LE, Exp Jul 2022; 12001312, Exp Aug 2022; 12001730, Exp Oct 2022; 12002071, 12100105, Exp Jan 2023; 12100222, Exp Mar 2023; 12100635, 12100636, Exp Jun 2023; c) 12000728, Exp Apr 2022; 12001119 LE, Exp Jul 2022; 12001631, Exp Oct 2022; 12001811, Exp Nov 2022; 12002115, 12002116, Exp Jan 2023; 12100221, Exp Feb 2023; 12100633, Exp May 2023; 12100634, 12100774, 12100817, Exp Jun 2023",
      "more_code_info": ""
    }
  ]
}