{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Deerfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "NDA018016"
        ],
        "brand_name": [
          "SODIUM CHLORIDE"
        ],
        "generic_name": [
          "SODIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Corporation"
        ],
        "product_ndc": [
          "0338-0043",
          "0338-0049"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "SODIUM CHLORIDE"
        ],
        "rxcui": [
          "1807551",
          "1807552",
          "1807627",
          "1807630",
          "1807631",
          "1807632",
          "1807633",
          "1807634",
          "1807639"
        ],
        "spl_id": [
          "8edef896-cfdd-43fe-a358-f4f82642c4c5"
        ],
        "spl_set_id": [
          "f55bd888-5e01-474d-871b-24654c070178"
        ],
        "package_ndc": [
          "0338-0049-01",
          "0338-0049-02",
          "0338-0049-03",
          "0338-0049-04",
          "0338-0049-10",
          "0338-0049-41",
          "0338-0049-11",
          "0338-0049-31",
          "0338-0049-48",
          "0338-0049-18",
          "0338-0049-38",
          "0338-0043-03",
          "0338-0043-04"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "451W47IQ8X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "67092",
      "recalling_firm": "Baxter Healthcare Corp.",
      "address_1": "1 Baxter Pkwy",
      "address_2": "",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.",
      "recall_number": "D-1163-2014",
      "product_description": "0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b)  100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), Rx only, Baxter Healthcare Corporation, Deerfield, IL  60015 USA.",
      "product_quantity": "716,544 containers",
      "reason_for_recall": "Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag",
      "recall_initiation_date": "20131121",
      "center_classification_date": "20140314",
      "termination_date": "20160921",
      "report_date": "20140326",
      "code_info": "Lot #: a) P297283, Exp 08/14; b) P292326, Exp 04/14; P293993, Exp 05/14; and P293514, Exp 04/14",
      "more_code_info": ""
    }
  ]
}