{
  "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": "Woodcliff Lake",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "PVP IODINE PREP PAD"
        ],
        "generic_name": [
          "PROVIDONE IODINE"
        ],
        "manufacturer_name": [
          "Professional Disposables International, Inc."
        ],
        "product_ndc": [
          "10819-3883",
          "10819-3885"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "POVIDONE-IODINE"
        ],
        "rxcui": [
          "797730"
        ],
        "spl_id": [
          "40ab78fb-f19d-ce27-e063-6294a90ae51d"
        ],
        "spl_set_id": [
          "50c524ab-7029-494a-8bb4-d90a4d184fb2"
        ],
        "package_ndc": [
          "10819-3883-1",
          "10819-3883-3",
          "10819-3885-1",
          "10819-3885-2",
          "0031081900"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175486",
          "M0011640"
        ],
        "pharm_class_epc": [
          "Antiseptic [EPC]"
        ],
        "pharm_class_cs": [
          "Iodine [CS]"
        ],
        "unii": [
          "85H0HZU99M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88326",
      "recalling_firm": "Professional Disposables International, Inc",
      "address_1": "400 Chestnut Ridge Rd",
      "address_2": "N/A",
      "postal_code": "07677-7604",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Nationwide in the US",
      "recall_number": "D-0760-2021",
      "product_description": "PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International, Inc. Orangeburg, NY 10962 -1376 Reorder No S41350 NDC 10819-3885-1, UPC (01)00310819000178.",
      "product_quantity": "41,105 cases",
      "reason_for_recall": "SubPotent: Out of Specification",
      "recall_initiation_date": "20210723",
      "center_classification_date": "20210820",
      "termination_date": "20230531",
      "report_date": "20210901",
      "code_info": "Lot #'s 11900790, EXP 2021-07-25; 11900919, EXP 2021-07-28; 11900920, EXP 2021-08-12;  11900921, EXP 2021-08-15; 11901106, EXP 2021-08-27; 11901107, EXP 2021-08-30; 11901128, EXP 2021-09-05; 11901129, EXP 2021-09-12;11901249, EXP 2021-09-25; 11901250, EXP 2021-10-17; 11901391, EXP 2021-10-19; 11901392, EXP 2021-10-22; 11901438, EXP 2021-10-24; 11901439, EXP 2021-10-08; 11901457, EXP 2021-11-07; 11901541, EXP 2021-11-18; 11901603, EXP 2021-11-19; 11901604, EXP 2021-12-19; 11901669, EXP 2021-12-19; 11901670, EXP 2021-11-16; 11901702, EXP 2021-12-02; 11901703, EXP 2021-12-14; 12000082, EXP 2021-12-19; 12000083, EXP 2022-01-24; 12000118, EXP 2022-01-03; 12000119, EXP 2022-01-30; 12000249, EXP 2022-01-10; 12000250, EXP 2022-01-10; 12000348, EXP 2022-02-13; 12000349, EXP 2022-02-28; 12000398, EXP 2022-02-05; 12000456, EXP 2022-03-12; 12000457, EXP 2022-03-12; 12000683, EXP 2022-03-23; 12000684, EXP 2022-03-30; 12000685, EXP 2022-04-04; 12000922, EXP 2022-05-15; 12000923, EXP 2022-05-19; 12000927, EXP 2022-05-21;  12000989, EXP 2022-06-15; 12000990, EXP 2022-06-05; 12000991, EXP 2022-06-10; 12001154, EXP 2022-06-26; 12001155, EXP 2022-06-24; 12001231, EXP 2022-07-26; 12001232, EXP 2022-07-21; 12001243, EXP 2022-07-03; 12001244, EXP 2022-07-04; 12001537, EXP 2022-08-31; 12001538, EXP 2022-08-31; 12001539, EXP 2022-08-31; 12001540, EXP 2022-09-30; 12001666, EXP 2022-09-30; 12001667, EXP 2022-09-30; 12001668, EXP 2022-09-30; 12001669, EXP 2022-09-30; 12001841, EXP 2022-10-31; 12001842, EXP 2022-10-31; 12001959, EXP 2022-10-31; 12002072, EXP 2022-11-30; 12100123, EXP 2023-02-28; 12100124, EXP 2023-02-28; 12100454, EXP 2023-03-31; 12100455, EXP 2023-03-31; 12100590, EXP 2023-04-30; 12100591, EXP 2023-04-30;"
    }
  ]
}