{
  "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": "Completed",
      "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": "92917",
      "recalling_firm": "CareFusion 213, LLC",
      "address_1": "1550 Northwestern Dr",
      "address_2": "",
      "postal_code": "79912-8000",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed nationwide to 100 consignees. Please refer to consignee list.",
      "recall_number": "D-1168-2023",
      "product_description": "BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-31 REF 930480  Product is packaged in the following manner: There is one (1) sterile applicator (sponge) per pouch. Each inner carton contains sixty (60) pouches. There are four (4) inner cartons per shipping case (total of 240 pouches per case).",
      "product_quantity": "398,160 cartons",
      "reason_for_recall": "Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep\" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.",
      "recall_initiation_date": "20230825",
      "center_classification_date": "20230915",
      "report_date": "20230927",
      "code_info": "Lot # 2272350, Exp. Date 09/30/2025 and Lot # 2301939, Exp. Date 09/30/2025",
      "more_code_info": ""
    }
  ]
}