{
  "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 II",
      "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": "65288",
      "recalling_firm": "Baxter Healthcare Corp.",
      "address_1": "1 Baxter Pkwy",
      "address_2": "N/A",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide & Puerto Rico",
      "recall_number": "D-628-2013",
      "product_description": "Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad Pack (NDC 0338-0049-11); b) 2B1302- 100mL in Viaflex Quad Pack (NDC 0338-0049-18); c) 2B1306- 50 mL in Viaflex Single Pack (NDC 0338-0049-41; d) 2B1307- 100mL in Viaflex Single Pack (NDC 0338-0049-48); e) 2B1308- 50 ML in Viaflex Multi Pack (NDC 0338-0049-31); f) 2B1309- 100mL in Viaflex Multi Pack (NDC 0338-0049-38), Rx Only, Baxter, Deerfield, IL 60015",
      "product_quantity": "1,788,292 units",
      "reason_for_recall": "Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.",
      "recall_initiation_date": "20130521",
      "center_classification_date": "20130628",
      "termination_date": "20150618",
      "report_date": "20130710",
      "code_info": "Lot #: a) Product code 2B1301: P279943, P280370, Exp 7/13; b) Product code 2B1302: P280248, P280248A, P280248B, P285346, P285791, Exp 8/13; c) Product code 2B1306: P285601, Exp 5/13; d) Product code 2B1307: P280347, Exp 8/13; e) Product code 2B1308: P280404, P280404A, P285635, P285858, Exp 11/13; e) Product code 2B1309: P280149, Exp 8/13"
    }
  ]
}