{
  "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": "North Brunswick",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "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": "76733",
      "recalling_firm": "Claris Lifesciences Inc",
      "address_1": "1445 US Highway 130",
      "address_2": "",
      "postal_code": "08902-3100",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0615-2017",
      "product_description": "Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL  5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-048-24",
      "product_quantity": "24,456 units (1019 cartons x 24 bags)",
      "reason_for_recall": "Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.",
      "recall_initiation_date": "20170310",
      "center_classification_date": "20170324",
      "termination_date": "20200918",
      "report_date": "20170405",
      "code_info": "Lot #: A060040, Exp. Dec 2017",
      "more_code_info": ""
    }
  ]
}