{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "El Paso",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "PURPREP"
        ],
        "generic_name": [
          "POVIDONE IODINE AND ISOPROPYL ALCOHOL"
        ],
        "manufacturer_name": [
          "CareFusion 213 LLC"
        ],
        "product_ndc": [
          "54365-014"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ISOPROPYL ALCOHOL",
          "POVIDONE-IODINE"
        ],
        "rxcui": [
          "1052725"
        ],
        "spl_id": [
          "40add5c5-68aa-96f9-e063-6294a90a7282"
        ],
        "spl_set_id": [
          "a1c6e118-7861-c8d0-e053-2995a90aeaaa"
        ],
        "package_ndc": [
          "54365-014-42",
          "54365-014-41"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175486",
          "M0011640"
        ],
        "pharm_class_epc": [
          "Antiseptic [EPC]"
        ],
        "pharm_class_cs": [
          "Iodine [CS]"
        ],
        "unii": [
          "ND2M416302",
          "85H0HZU99M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98790",
      "recalling_firm": "CareFusion 213, LLC",
      "address_1": "1550 Northwestern Dr",
      "address_2": "",
      "postal_code": "79912-8000",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0517-2026",
      "product_description": "BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.",
      "product_quantity": "",
      "reason_for_recall": "Lack of assurance of Sterility: potential product contamination",
      "recall_initiation_date": "20260422",
      "center_classification_date": "20260505",
      "report_date": "20260513",
      "code_info": "Lot# 4258309,  4260329,  4256875, Exp. Date, 08-31-2026; 4296453, 4317319, 4290654,   Exp. Date 09-30-2026; 4322449, 4323861, 4318679, Exp Date 10-31- Exp.",
      "more_code_info": ""
    }
  ]
}