{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Northfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "POVIDONE-IODINE"
        ],
        "generic_name": [
          "POVIDONE-IODINE"
        ],
        "manufacturer_name": [
          "Medline Industries, LP"
        ],
        "product_ndc": [
          "53329-938"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "POVIDONE-IODINE"
        ],
        "rxcui": [
          "211747"
        ],
        "spl_id": [
          "41c65656-ff98-67e5-e063-6394a90a6079"
        ],
        "spl_set_id": [
          "2b95078e-2caf-7005-e054-00144ff88e88"
        ],
        "package_ndc": [
          "53329-938-06",
          "53329-938-08",
          "53329-938-23",
          "53329-938-25",
          "53329-938-04"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175486",
          "M0011640"
        ],
        "pharm_class_epc": [
          "Antiseptic [EPC]"
        ],
        "pharm_class_cs": [
          "Iodine [CS]"
        ],
        "unii": [
          "85H0HZU99M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79267",
      "recalling_firm": "Medline Industries Inc",
      "address_1": "Three Lakes Drive",
      "address_2": "N/A",
      "postal_code": "60093",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA and Curacao",
      "recall_number": "D-0546-2018",
      "product_description": "PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA by Medline Industries, Inc., Northfield, IL 60093; Product Number MDS093945; NDC 53329-938-04",
      "product_quantity": "67,104 bottles",
      "reason_for_recall": "Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.",
      "recall_initiation_date": "20180215",
      "center_classification_date": "20180226",
      "termination_date": "20200429",
      "report_date": "20180307",
      "code_info": "Lot #: 16EJ0023, Exp 04/18"
    }
  ]
}