{
  "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": "El Paso",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "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": "96879",
      "recalling_firm": "CareFusion 213, LLC",
      "address_1": "1550 Northwestern Dr",
      "address_2": "N/A",
      "postal_code": "79912-8000",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the U.S.",
      "recall_number": "D-0441-2025",
      "product_description": "BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.",
      "product_quantity": "385,200 applicators",
      "reason_for_recall": "Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.",
      "recall_initiation_date": "20250515",
      "center_classification_date": "20250520",
      "report_date": "20250528",
      "code_info": "Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026"
    }
  ]
}