{
  "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": "2026-07-29",
    "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": "88539",
      "recalling_firm": "AVRIO HEALTH L.P",
      "address_1": "201 Tresser Blvd",
      "address_2": "",
      "postal_code": "06901-3435",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed nationwide.",
      "recall_number": "D-0828-2021",
      "product_description": "Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single  and three count Antispetic Non-Sterile Solution   Avrio Health LP Stamford, CT 06901-3431  NDC 67618-153-01, NDC 67618-153-03",
      "product_quantity": "75,828 shippers",
      "reason_for_recall": "Subpotent Drug",
      "recall_initiation_date": "20210826",
      "center_classification_date": "20210923",
      "termination_date": "20230412",
      "report_date": "20210929",
      "code_info": "Lot #  11901232, Exp. Date 09/30/2021  11901549, Exp. Date 11/30/2021  12000585, Exp. Date 03/31/2022  12000964, Exp. Date 5/31/2022  12001457, Exp. Date 7/31/2022  12002142, Exp. Date 12/31/2022  12100407, Exp. Date 03/31/2023  11901231, Exp. Date 09/30/2021  11901548, Exp. Date 11/30/2021  12000584, Exp. Date 03/31/2022  12000963, Exp. Date 05/31/2022  12001185, Exp. Date 06/30/2022  12001456, Exp. Date 07/31/2022  12002150, Exp. Date 12/31/2022  12100406, Exp. Date 03/31/2023",
      "more_code_info": ""
    }
  ]
}