{
  "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": [
          "NDA019615"
        ],
        "brand_name": [
          "DOPAMINE HYDROCHLORIDE AND DEXTROSE"
        ],
        "generic_name": [
          "DOPAMINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Corporation"
        ],
        "product_ndc": [
          "0338-1005",
          "0338-1007",
          "0338-1009"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "DOPAMINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1292887",
          "1743869",
          "1743871",
          "1743877",
          "1743879"
        ],
        "spl_id": [
          "edc9a091-4cb5-4ec7-b6f9-44d2d588bab9"
        ],
        "spl_set_id": [
          "cb97d4a0-89ed-407c-a763-209386b6f75c"
        ],
        "package_ndc": [
          "0338-1005-02",
          "0338-1005-03",
          "0338-1007-02",
          "0338-1007-03",
          "0338-1009-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "7L3E358N9L"
        ]
      },
      "product_type": "Drugs",
      "event_id": "69303",
      "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 and Canada",
      "recall_number": "D-0004-2015",
      "product_description": "DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only,  Baxter USA, NDC 0338-1005-02.",
      "product_quantity": "11,808 bags",
      "reason_for_recall": "Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.",
      "recall_initiation_date": "20140929",
      "center_classification_date": "20141002",
      "termination_date": "20160930",
      "report_date": "20141008",
      "code_info": "Lot#  P303172; Exp. 12/14"
    }
  ]
}