{
  "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 MAXI SWABSTICK"
        ],
        "generic_name": [
          "CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL"
        ],
        "manufacturer_name": [
          "Professional Disposables International, Inc."
        ],
        "product_ndc": [
          "10819-4076"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CHLORHEXIDINE GLUCONATE",
          "ISOPROPYL ALCOHOL"
        ],
        "rxcui": [
          "1191171",
          "1366736"
        ],
        "spl_id": [
          "f5aff4be-ddc9-63ad-e053-2a95a90a426b"
        ],
        "spl_set_id": [
          "93ca3c07-40b4-3a91-e053-2995a90a0afd"
        ],
        "package_ndc": [
          "10819-4076-4",
          "10819-4076-3"
        ],
        "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-0570-2022",
      "product_description": "Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 30 Individual Maxi Swabsticks per carton, 10 boxes of 30 Individual Swabsticks per case, NDC 10819-4076-4, REORDER NO. S41950; b) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 300 Individual Swabsticks per case, NDC 10819-4076-3, REORDER NO. S27350; Professional Disposables International, Inc., Orangeburg, NY  10962-1376.",
      "product_quantity": "a) 9518 cases; b) 3347 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) 12000315, Exp Feb 2022; 12000700, Exp Mar 2022; 12001112 LE, Exp Jun 2022; 12001214, Exp Jul 2022; 12001362, 12001406, Exp Aug 2022; 12001628, Exp Sep 2022; 12001856, Exp Oct 2022; 12002103, Exp Dec 2022; 12002113, 12100024, Exp Jan 2023; 12100226, 12100227, Exp Feb 2023; 12100443, 12100503, Exp Mar 2023; 12100516, 12100517, Exp Apr 2023; 12100748, 12100756, Exp May 2023; b) 12001113 LE, Exp Jun 2022; 12001289, 12001240, Exp Jul 2022; 12002104, Exp Dec 2022; 12100025, Exp Jan 2023; 12100405, Exp Mar 2023; 12100674, Exp Apr 2023; 12100779, Exp May 2023",
      "more_code_info": ""
    }
  ]
}