{
  "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": [
          "NDA018609"
        ],
        "brand_name": [
          "HEPARIN SODIUM IN SODIUM CHLORIDE"
        ],
        "generic_name": [
          "HEPARIN SODIUM"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Corporation"
        ],
        "product_ndc": [
          "0338-0424",
          "0338-0431",
          "0338-0433",
          "0338-0428"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "HEPARIN SODIUM"
        ],
        "rxcui": [
          "1658690",
          "1658692"
        ],
        "spl_id": [
          "68b37381-6db4-4ac0-ba6b-3204add02665"
        ],
        "spl_set_id": [
          "0d929726-76c3-48fc-b4e7-fd06409f9fb3"
        ],
        "package_ndc": [
          "0338-0431-03",
          "0338-0433-04",
          "0338-0424-18",
          "0338-0428-12"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "ZZ45AB24CA"
        ]
      },
      "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-626-2013",
      "product_description": "Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000mL, (NDC 0338-0433-04), b) Product code 2B0953: 1000 USP Units, Viaflex Plus Container, 500 mL (NDC 0338-0431-03), Baxter, Deerfield, IL 60015",
      "product_quantity": "N/A",
      "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 2B0944: N001164, Exp 7/13; b) Product code 2B0953: N001396, Exp 11/13"
    }
  ]
}