{
  "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 I",
      "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"
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        "spl_id": [
          "8cb7f273-fc11-48e7-b2ef-a5290ab7ac4e"
        ],
        "spl_set_id": [
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        ],
        "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": "78932",
      "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": "Press Release",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0574-2018",
      "product_description": "Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics Pharma LLC 6 Wheeling Drive, Dayton, NJ 08810  Manufactured for: Aurobindo Pharma Limited IDA, Pashamylaram - 502307, India ----  NDC 55150-243-46",
      "product_quantity": "6,072 bags",
      "reason_for_recall": "Presence of Particulate Matter; contains visible particulate matter identified as mold.",
      "recall_initiation_date": "20180112",
      "center_classification_date": "20180301",
      "termination_date": "20200401",
      "report_date": "20180307",
      "code_info": "Lot CLF160003, exp May 2018"
    }
  ]
}