{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA016733"
        ],
        "brand_name": [
          "SODIUM CHLORIDE"
        ],
        "generic_name": [
          "SODIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "B. Braun Medical Inc."
        ],
        "product_ndc": [
          "0264-2201"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "IRRIGATION"
        ],
        "substance_name": [
          "SODIUM CHLORIDE"
        ],
        "rxcui": [
          "486515"
        ],
        "spl_id": [
          "35e26a6d-60d6-4388-84e9-c481a3b69ee7"
        ],
        "spl_set_id": [
          "0d59a04a-32e6-485b-b638-a1e6c09e9642"
        ],
        "package_ndc": [
          "0264-2201-00",
          "0264-2201-10",
          "0264-2201-50",
          "0264-2201-70"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "451W47IQ8X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79348",
      "recalling_firm": "B. Braun Medical Inc",
      "address_1": "2525 McGaw Ave",
      "address_2": "N/A",
      "postal_code": "92614-5841",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0549-2018",
      "product_description": "0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA  92614, Catalog # R5200-01, NDC 0264-2201-00.",
      "product_quantity": "17,360 plastic irrigation containers",
      "reason_for_recall": "Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.",
      "recall_initiation_date": "20180216",
      "center_classification_date": "20180227",
      "termination_date": "20200123",
      "report_date": "20180307",
      "code_info": "Batch # J7N912, Exp 10/31/20"
    }
  ]
}