{
  "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": "Stamford",
      "state": "CT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M003"
        ],
        "brand_name": [
          "BETADINE"
        ],
        "generic_name": [
          "POVIDONE-IODINE"
        ],
        "manufacturer_name": [
          "Atlantis Consumer Healthcare, Inc."
        ],
        "product_ndc": [
          "67618-153"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "POVIDONE-IODINE"
        ],
        "rxcui": [
          "797730",
          "798176"
        ],
        "spl_id": [
          "4357dde4-a121-3be4-e063-6394a90af3c8"
        ],
        "spl_set_id": [
          "0707b259-52a4-4ae6-b176-d093865906e7"
        ],
        "package_ndc": [
          "67618-153-01",
          "67618-153-03"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175486",
          "M0011640"
        ],
        "pharm_class_epc": [
          "Antiseptic [EPC]"
        ],
        "pharm_class_cs": [
          "Iodine [CS]"
        ],
        "unii": [
          "85H0HZU99M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78229",
      "recalling_firm": "Purdue Pharma, LP",
      "address_1": "1 Stamford Forum",
      "address_2": "N/A",
      "postal_code": "06901-3516",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0070-2018",
      "product_description": "Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01",
      "product_quantity": "3997 swabsticks",
      "reason_for_recall": "Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum.",
      "recall_initiation_date": "20171005",
      "center_classification_date": "20171103",
      "termination_date": "20200124",
      "report_date": "20171115",
      "code_info": "Lots: 62823 Exp. 12/31/18; 64304 Exp. 05/31/2019; 64711 Exp. 08/31/2019; 65915 Exp. 12/31/2019"
    }
  ]
}