{
  "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": "2026-07-08",
    "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"
        ],
        "upc": [
          "118009792021",
          "118012282021",
          "118014192021",
          "118017092021",
          "119001972022",
          "119003712022",
          "119006472022",
          "119006232022",
          "119009682022",
          "119013302022",
          "119014462022",
          "120000482023",
          "120013662023",
          "120019772023",
          "121000822024"
        ]
      },
      "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-0758-2021",
      "product_description": "PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc., Orangeburg, NY 10962-1376 Reorder No. B40600; UPC (01)00310819000147, NDC 10819-3883-1,",
      "product_quantity": "53588 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       EXP date 11800977, 2021-07-31;  11800978 2021-08-02; 11800979 2021-08-04; 11801123 2021-08-06; 11801124 2021-08-09; 11801125 2021-08-15; 11801126 2021-08-16; 11801228 2021-08-28; 11801230 2021-09-11; 11801231 2021-09-13; 11801232 2021-09-18; 11801234 2021-10-25; 11801417 2021-10-28; 11801418 2021-11-01; 11801419 2021-11-07; 11801420 2021-11-15; 11801421 2021-11-20; 11801709 2021-11-29; 11801710 2021-12-04; 11900195 2022-02-19; 11900196 2022-02-21; 11900197 2022-02-25; 11900370 2022-04-01; 11900372 2022-04-03; 11900371 2022-04-05; 11900647 2022-05-04; 11900623 2022-05-21; 11900624 2022-05-24; 11900646 2022-05-29; 11900967 2022-08-13; 11900968 2022-08-26; 11900969 2022-08-28; 11901043 2022-09-11; 11901044 2022-09-18; 11901318 2022-10-03; 11901330 2022-10-08; 11901331 2022-10-16; 11901446 2022-10-28; 11901447 2022-11-19; 11901448 2022-12-19; 11901739 2023-01-02; 11901752 2023-01-09; 12000045 2023-01-14; 12000048 2023-01-18; 12000046 2023-01-21; 12000047 2023-01-24; 12000333 2023-01-25; 12000675 2023-02-16; 12000334 2023-02-27; 12000335 2023-02-27; 12000336 2023-02-28; 12000676 2023-03-16; 12000815 2023-03-29; 12000816 2023-05-05; 12000914 2023-05-13; 12000915 2023-05-18; 12000951 2023-05-22; 12000950 2023-06-01; 12001366 2023-08-12; 12001367 2023-08-14; 12001368 2023-08-17; 12001370 2023-08-21; 12001369 2023-08-21; 12001371 2023-08-25; 12001372 2023-09-30; 12001818 2023-09-30; 12001820 2023-09-30; 12001819 2023-11-30; 12001821 2023-11-30; 12001822 2023-11-30; 12001972 2023-12-31; 12001973 2023-12-31; 12001974 2023-12-31; 12001975 2023-12-31; 12001976 2023-12-31; 12001977 2023-12-31; 12001978 2023-12-31; 12100080 2023-12-31; 12100081 2023-12-31; 12100082 2024-02-29; 12100084 2024-02-29; 12100447 2024-03-31;                  11800978, 11800979, 11801123, 11801124, 11801125, 11801126, 11801228, 11801230, 11801231, 11801232, 11801234, 11801417,11801418, 11801419,  11801420, 11801421, 11801709, 11801710, 11900195, 11900196, 11900197, 11900370, 11900371, 11900372, 11900623, 11900624, 11900646, 11900647, 11900967, 11900968, 11900969, 11901043, 11901044, 11901318, 11901330, 11901331, 11901446, 11901447, 11901448, 11901739, 11901752, 12000045, 12000046, 12000047, 12000048, 12000333,  12000334, 12000335, 12000336, 12000675, 12000676, 12000815, 12000816, 12000914, 12000915, 12000950, 12000951, 12001366, 12001367, 12001368, 12001369, 12001370,  12001371, 12001372, 12001818, 12001819, 12001820, 12001821, 12001822, 12001972, 12001973, 12001974, 12001975, 12001976, 12001977, 12001978, 12100080, 12100081, 12100082, 12100084 and 12100447"
    }
  ]
}