{
  "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 SWAB"
        ],
        "generic_name": [
          "CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL"
        ],
        "manufacturer_name": [
          "Professional Disposables International, Inc."
        ],
        "product_ndc": [
          "10819-1080"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CHLORHEXIDINE GLUCONATE",
          "ISOPROPYL ALCOHOL"
        ],
        "rxcui": [
          "1191171",
          "1366736"
        ],
        "spl_id": [
          "079d6f47-65e3-2f14-e063-6394a90a444a",
          "078de79b-c16c-78f8-e063-6294a90a384a"
        ],
        "spl_set_id": [
          "db61e7fd-c421-4e3c-bc88-0343230273de",
          "ff999b50-0b6b-404e-b4f1-c6694fe47a9b"
        ],
        "package_ndc": [
          "10819-1080-1",
          "10819-1080-2"
        ],
        "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-0571-2022",
      "product_description": "Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swab, 0.034 fl. Oz. (1 mL) Each in a pouch, 100 Individual Swabs per carton, 10 boxes of 100 Individual Swabs per case, REORDER NO. B10800, NDC 10819-1080-1; b) One Swab, 0.034 fl. oz. (1 mL) Each in a pouch, 3000 Individual Swabs per case, REORDER NO. B11400, NDC 10819-1080-2; Professional Disposables International, Inc., Orangeburg, NY  10962-1376.",
      "product_quantity": "a) 160531 cases; b) 16123 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) 12000165, 12000166, 12000382, Exp Feb 2022; 12000228, 12000381, 12000383, 12000577, 12000578, 12000579, 12000661, 12000662, Exp Mar 2022; 12000659, 12000660, Exp Apr 2022; 12001060, 12001061, 12001062, 12001100 LE, 12001101 LE, Exp Jun 2022;  12001233, 12001234, 12001235, 12001236, Exp Jul 2022; 12001351, 12001394, 12001395, 12001396, 12001397, 12001398, 12001399, Exp Aug 2022; 12001632,12001633, 12001634, 12001635, 12001636, Exp Sep 2022; 12001637, 12001638, 12001639, 12001640, 12001641, 12001721, 12001791, Exp Oct 2022; 12001792, 12001793, 12001794, 12001962, Exp Nov 2022; 12002039, 12002040, 12100014, 12100015, 12100016, 12100017,  12100035, 12100036, 12100037, 12100074, 12100183, 12100184, Exp Jan 2023; 12100018, 12100185, 12100186, 12100192, 12100193, 12100194, 12100195, 12100241, 12100242, 12100243, 12100244, 12100245, 12100246, 12100247, 12100277, Exp Feb 2023; 12100312, 12100313, 12100347, 12100348, 12100349, Exp Mar 2023; 12100350, 12100351, 12100543, 12100638, Exp Apr 2023; 12100541, 12100542, 12100639, 12100732, 12100733, 12100753, 12100754, Exp May 2023; 12100755, 12100790, 12100791, 12100824, Exp Jun 2023; b) 12000194, 12000195, Exp Feb 2022; 12000500, 12000570, 12000594, 12000698, Exp Mar 2022; 12001058, 12001059, 12001069, 12001108 LE, 12001109 LE, 12001110 LE, Exp Jun 2022; 12001111 LE, 12001225, 12001226, 12001227, 12001228, 12001229, 12001230, Exp Jul 2022; 12001393, 12001522, Exp Aug 2022; 12001734, 12001735, 12001736, 12001737, Exp Oct 2022; 12001854, Exp Nov 2022; 12002033, 12002035, 12002045, 12002046, Exp Dec 2022; 12100019, 12100020, 12100021, 12100022, 12100096, 12100097, 12100098, 12100099, Exp Jan 2023; 12100196, 12100197, 12100251, 12100252, 12100253, 12100254, 12100255, 12100256, 12100257, 12100346, Exp Feb 2023; 12100363,12100364, 12100365, 12100366, Exp Mar 2023; 12100518, 12100519, 12100520, 12100521, Exp Apr 2023; 12100691, 12100693, Exp May 2023",
      "more_code_info": ""
    }
  ]
}