{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Waltham",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M018"
        ],
        "brand_name": [
          "IVIZIA DRY EYE"
        ],
        "generic_name": [
          "POVIDONE"
        ],
        "manufacturer_name": [
          "Thea Pharma Inc."
        ],
        "product_ndc": [
          "82584-700"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "POVIDONE"
        ],
        "rxcui": [
          "2570860",
          "2586186"
        ],
        "spl_id": [
          "4197af7c-fb98-684b-e063-6394a90a64cf"
        ],
        "spl_set_id": [
          "1ef73cb1-da48-a713-e063-6294a90afa9d"
        ],
        "package_ndc": [
          "82584-700-05",
          "82584-700-11",
          "82584-700-13"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "FZ989GH94E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98792",
      "recalling_firm": "Thea Pharma, Inc.",
      "address_1": "303 Wyman St",
      "address_2": "",
      "postal_code": "02451-1208",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0500-2026",
      "product_description": "iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11",
      "product_quantity": "",
      "reason_for_recall": "Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.",
      "recall_initiation_date": "20260423",
      "center_classification_date": "20260428",
      "report_date": "20260506",
      "code_info": "Lot#: 3T36B, Exp. Date October 31, 2026.",
      "more_code_info": ""
    }
  ]
}