{
  "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": [
          "ANDA207160"
        ],
        "brand_name": [
          "LEVETIRACETAM"
        ],
        "generic_name": [
          "LEVETIRACETAM IN SODIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Eugia US LLC"
        ],
        "product_ndc": [
          "55150-246",
          "55150-247",
          "55150-248"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "LEVETIRACETAM"
        ],
        "rxcui": [
          "1193358",
          "1193360",
          "1193362"
        ],
        "spl_id": [
          "2e0b32db-b6e3-4a68-a752-e4923f4bd84a"
        ],
        "spl_set_id": [
          "e5eb4c89-8ee9-4474-9cb1-c3b3dc262a4a"
        ],
        "package_ndc": [
          "55150-246-47",
          "55150-247-47",
          "55150-248-47"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355150248476"
        ],
        "nui": [
          "N0000008486"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "unii": [
          "44YRR34555"
        ]
      },
      "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-0707-2018",
      "product_description": "Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-248-47.",
      "product_quantity": "67300 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:    CLV160004, CLV160005, and CLV160006 exp September 2018; CLV170011,   CLV170015, CLV170016 exp June 2019"
    }
  ]
}