{
  "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": "80987",
      "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 USA and Puerto Rico",
      "recall_number": "D-1215-2018",
      "product_description": "Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India.",
      "product_quantity": "523,896 bags",
      "reason_for_recall": "Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.",
      "recall_initiation_date": "20180925",
      "center_classification_date": "20180927",
      "termination_date": "20200626",
      "report_date": "20181003",
      "code_info": "Lot #: a) A061178, A061183, A061236, Exp. Date 09/2018; A0A0937, Exp. Date 08/2019; A0A1044, A0A1048, Exp. Date 10/2019.  b) A0A0741, A0A0747, A0A0748, Exp. Date 6/2019; A0A0814, A0A0815, A0A0823, Exp.Date 7/2019; A0A0889, A0A0893, Exp. Date 8/2019; A0A0954, A0A0958, A0A0970, Exp. Date 09/2019; A0A1005, A0A1006, A0A1008, A0A1012, A0A1016, A0A1028, A0A1036, Exp. 10/2019.  c) A061243, Exp. Date 09/2018;  A0A0258, Exp. Date 2/2019; A0A0813, Exp. Date 07/2019; A0A0899, A0A0904, A0A0907, A0A0914, A0A0916, A0A0921, A0A0925, Exp. Date 08/2019; A0A0971, A0A0976, Exp. Date 09/2019; A0A0994, A0A0996, A0A0997, A0A0999, A0A1000, A0A1001, A0A1003, A0A1004, Exp. Date 10/2019",
      "more_code_info": ""
    }
  ]
}