{
  "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": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206919"
        ],
        "brand_name": [
          "LEVOFLOXACIN"
        ],
        "generic_name": [
          "LEVOFLOXACIN IN 5% DEXTROSE"
        ],
        "manufacturer_name": [
          "Eugia US LLC"
        ],
        "product_ndc": [
          "55150-243",
          "55150-244",
          "55150-245"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "LEVOFLOXACIN"
        ],
        "rxcui": [
          "1665497",
          "1665507",
          "1665515"
        ],
        "spl_id": [
          "8cb7f273-fc11-48e7-b2ef-a5290ab7ac4e"
        ],
        "spl_set_id": [
          "7d3f83bf-2db7-4657-9538-406adf321ad5"
        ],
        "package_ndc": [
          "55150-243-46",
          "55150-244-47",
          "55150-245-52"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355150244478"
        ],
        "nui": [
          "N0000193223",
          "M0372253"
        ],
        "pharm_class_epc": [
          "Fluoroquinolone Antibacterial [EPC]"
        ],
        "pharm_class_cs": [
          "Fluoroquinolones [CS]"
        ],
        "unii": [
          "6GNT3Y5LMF"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79772",
      "recalling_firm": "AuroMedics Pharma LLC",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "N/A",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide",
      "recall_number": "D-0708-2018",
      "product_description": "Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-244-47",
      "product_quantity": "308472 bags",
      "reason_for_recall": "Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap",
      "recall_initiation_date": "20180327",
      "center_classification_date": "20180503",
      "termination_date": "20220218",
      "report_date": "20180509",
      "code_info": "Lot/Batch #'s:    CLF160008, CLF160009, CLF160010, CLF160011, exp June 2018; CLF160015, CLF160016 , CLF160017, exp August 2018; CLF170001 exp December 2018; CLF170023, CLF170024, exp May 2019; CLF170039, CLF170040, CLF170041, CLF170042, CLF170043, CLF170044, CLF170045, CLF170046, CLF170047 exp August 2019"
    }
  ]
}