{
  "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 III",
      "openfda": {
        "application_number": [
          "ANDA091436"
        ],
        "brand_name": [
          "LEVOFLOXACIN"
        ],
        "generic_name": [
          "LEVOFLOXACIN"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Corporation"
        ],
        "product_ndc": [
          "36000-045",
          "36000-046",
          "36000-047",
          "36000-048"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "LEVOFLOXACIN"
        ],
        "rxcui": [
          "1665497",
          "1665507",
          "1665515",
          "1665517"
        ],
        "spl_id": [
          "3cbc7b81-fabf-4666-951c-76f19e4f3222"
        ],
        "spl_set_id": [
          "70c87464-1806-480a-8ebd-3f02987ff436"
        ],
        "package_ndc": [
          "36000-045-01",
          "36000-046-24",
          "36000-047-24",
          "36000-048-24"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0336000047241",
          "0336000045018",
          "0336000046244"
        ],
        "nui": [
          "N0000193223",
          "M0372253"
        ],
        "pharm_class_epc": [
          "Fluoroquinolone Antibacterial [EPC]"
        ],
        "pharm_class_cs": [
          "Fluoroquinolones [CS]"
        ],
        "unii": [
          "6GNT3Y5LMF"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80653",
      "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": "Nationwide USA and Puerto Rico",
      "recall_number": "D-1035-2018",
      "product_description": "Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-047-24.",
      "product_quantity": "106,320 bags",
      "reason_for_recall": "Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.",
      "recall_initiation_date": "20180801",
      "center_classification_date": "20180803",
      "termination_date": "20200716",
      "report_date": "20180815",
      "code_info": "Lot#: A0A0954, A0A0958, A0A0970, Exp 09/19"
    }
  ]
}