{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "El Paso",
      "state": "TX",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "NDA020832"
        ],
        "brand_name": [
          "CHLORAPREP ONE-STEP"
        ],
        "generic_name": [
          "CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL"
        ],
        "manufacturer_name": [
          "CareFusion 213, LLC"
        ],
        "product_ndc": [
          "54365-400"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CHLORHEXIDINE GLUCONATE",
          "ISOPROPYL ALCOHOL"
        ],
        "rxcui": [
          "858726",
          "998282"
        ],
        "spl_id": [
          "42c769de-f1e0-b3a1-e063-6394a90ab2a1"
        ],
        "spl_set_id": [
          "85291b2b-40b9-07fa-e053-2a91aa0a84e4"
        ],
        "package_ndc": [
          "54365-400-31"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "MOR84MUD8E",
          "ND2M416302"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96262",
      "recalling_firm": "CareFusion 213, LLC",
      "address_1": "1550 Northwestern Dr",
      "address_2": "",
      "postal_code": "79912-8000",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide and Canada",
      "recall_number": "D-0259-2025",
      "product_description": "BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.",
      "product_quantity": "205,440 applicators",
      "reason_for_recall": "Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.",
      "recall_initiation_date": "20250214",
      "center_classification_date": "20250307",
      "report_date": "20250319",
      "code_info": "Lot #: 3200240, Exp 6/30/2026",
      "more_code_info": ""
    }
  ]
}