{
  "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": [
          "NDA019734"
        ],
        "brand_name": [
          "CARDENE IV"
        ],
        "generic_name": [
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        "manufacturer_name": [
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        ],
        "product_ndc": [
          "43066-009",
          "43066-016"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "NICARDIPINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "858599",
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          "858605"
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        "spl_id": [
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        "spl_set_id": [
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        "package_ndc": [
          "43066-016-10",
          "43066-009-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "K5BC5011K3"
        ]
      },
      "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-0813-2026",
      "product_description": "CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-016-10.",
      "product_quantity": "N/A",
      "reason_for_recall": "CGMP Deviations",
      "recall_initiation_date": "20260806",
      "center_classification_date": "20260828",
      "report_date": "20260909",
      "code_info": "Lot # NC177818, Exp Date: 12/31/2026; Lot # NC188869, Exp Date: 12/31/2027.",
      "more_code_info": ""
    }
  ]
}