{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Deerfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "NDA022325"
        ],
        "brand_name": [
          "NEXTERONE"
        ],
        "generic_name": [
          "AMIODARONE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Company"
        ],
        "product_ndc": [
          "43066-150",
          "43066-360"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "AMIODARONE HYDROCHLORIDE"
        ],
        "rxcui": [
          "849876",
          "1046406",
          "1046408",
          "1046410"
        ],
        "spl_id": [
          "aff0eecb-d97f-44bd-b149-5115dcacec53"
        ],
        "spl_set_id": [
          "e9108958-b8d7-4fba-87c3-9a32990de551"
        ],
        "package_ndc": [
          "43066-150-10",
          "43066-360-20"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "976728SY6Z"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78531",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "address_2": "",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within USA and Puerto Rico",
      "recall_number": "D-0573-2018",
      "product_description": "Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag,  Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10",
      "product_quantity": "35,628 single-dose containers",
      "reason_for_recall": "Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged",
      "recall_initiation_date": "20171110",
      "center_classification_date": "20180301",
      "termination_date": "20180829",
      "report_date": "20180207",
      "code_info": "Lot #, Expiry: NC109925, Exp 6/1/2019; NC109123, 5/2019",
      "more_code_info": ""
    }
  ]
}