{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Quzhou",
      "state": "",
      "country": "China",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M003"
        ],
        "brand_name": [
          "FIRST AID ANTISEPTIC"
        ],
        "generic_name": [
          "POVIDONE-IODINE"
        ],
        "manufacturer_name": [
          "Rugby Laboratories"
        ],
        "product_ndc": [
          "0536-1271"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "POVIDONE-IODINE"
        ],
        "rxcui": [
          "312563"
        ],
        "spl_id": [
          "38911ca2-7c18-5096-e063-6394a90a6121"
        ],
        "spl_set_id": [
          "b2bcb69e-8ffb-23ee-e053-2995a90aee21"
        ],
        "package_ndc": [
          "0536-1271-80"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0305361271800"
        ],
        "nui": [
          "N0000175486",
          "M0011640"
        ],
        "pharm_class_epc": [
          "Antiseptic [EPC]"
        ],
        "pharm_class_cs": [
          "Iodine [CS]"
        ],
        "unii": [
          "85H0HZU99M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95422",
      "recalling_firm": "Zhejiang Jingwei Pharmaceutical Co., Ltd.",
      "address_1": "Wengjia Road, Changshan Industrial Park No.19",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed to one wholesaler in OH for Nationwide distribution.",
      "recall_number": "D-0013-2025",
      "product_description": "First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC:  0536-1271-80",
      "product_quantity": "295,164 tubes",
      "reason_for_recall": "Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as \"mineral oil , petrolatum \". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.",
      "recall_initiation_date": "20240911",
      "center_classification_date": "20241017",
      "report_date": "20241023",
      "code_info": "Lot, expiry:   Lot 220901, Exp. 09/30/2024; Lot 230701, Exp. 07/31/2026; Lot 230301, Exp. 03/31/2026; Lot 230401, Exp. 04/30/2026; Lot 230501, Exp. 05/31/2026; Lot 230801, Exp. 08/31/2026; Lot 240301, Exp. 03/31/2027; Lot 240501, Exp. 04/30/2027.",
      "more_code_info": ""
    }
  ]
}