{
  "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": [
          "NDA016673"
        ],
        "brand_name": [
          "DEXTROSE"
        ],
        "generic_name": [
          "DEXTROSE MONOHYDRATE"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Corporation"
        ],
        "product_ndc": [
          "0338-0017",
          "0338-0023"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "DEXTROSE MONOHYDRATE"
        ],
        "rxcui": [
          "1795477",
          "1795480",
          "1795481",
          "1795607",
          "1795609",
          "1795610",
          "1795612",
          "1795616",
          "1795618"
        ],
        "spl_id": [
          "31bb4a5f-733e-4354-9fbf-138dede4db0f"
        ],
        "spl_set_id": [
          "3bb406a9-f5cb-403a-b1bb-5c4facbea3d5"
        ],
        "package_ndc": [
          "0338-0017-10",
          "0338-0017-41",
          "0338-0017-11",
          "0338-0017-31",
          "0338-0017-48",
          "0338-0017-18",
          "0338-0017-38",
          "0338-0017-02",
          "0338-0017-03",
          "0338-0017-04",
          "0338-0023-02",
          "0338-0023-03",
          "0338-0023-04"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "LX22YL083G"
        ]
      },
      "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-625-2013",
      "product_description": "5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b) 100 mL (NDC 0338-0017-38), Baxter, Deerfield, IL 60015",
      "product_quantity": "730,848 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 2B0088: P280115, P285239, Exp 7/13; b) Product code 2B0089: P280230, P280461, P285288, P285288A, P285783, Exp 8/13"
    }
  ]
}