{
  "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": "2026-09-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Deerfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA022325"
        ],
        "brand_name": [
          "NEXTERONE"
        ],
        "generic_name": [
          "AMIODARONE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Corporation"
        ],
        "product_ndc": [
          "43066-150",
          "43066-360"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "AMIODARONE HYDROCHLORIDE"
        ],
        "rxcui": [
          "849876",
          "1046406",
          "1046408",
          "1046410"
        ],
        "spl_id": [
          "86598704-4a32-4696-b2c2-2861e28db76a"
        ],
        "spl_set_id": [
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        "package_ndc": [
          "43066-150-10",
          "43066-360-20"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "976728SY6Z"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99500",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "address_2": "N/A",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide; Puerto Rico; and Chile.",
      "recall_number": "D-0814-2026",
      "product_description": "Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20.",
      "product_quantity": "N/A",
      "reason_for_recall": "CGMP Deviations",
      "recall_initiation_date": "20260806",
      "center_classification_date": "20260828",
      "report_date": "20260909",
      "code_info": "Lot # NC177832, Exp Date: 12/31/2026; Lot # NC185417, NC185455, Exp Date: 08/31/2027; Lot # NC188593, Exp Date: 11/30/2027; Lot # NC188647, NC188685, NC188807, NC188838, NC188920, Exp Date: 12/31/2027; Lot # NC193603, NC193726, NC193788, NC193863, NC193900, Exp Date: 04/30/2028; Lot # NC194082, NC194112, NC194143, NC195157, Exp Date: 05/31/2028.",
      "more_code_info": ""
    }
  ]
}