{
  "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-0705-2018",
      "product_description": "Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-246-47.",
      "product_quantity": "261250 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:  CLV160016, CLV160017, and CLV160018, exp Sept 2018, CLV160019, exp Oct 2018, CLV160020, CLV160021, and CLV160031, exp Nov 2018; CLV160032 and CLV170001, exp 12/18; CLV170008 and CLV170009, exp April 2019, CLV170020, CLV170021 and CLV170022, exp Oct 2019"
    }
  ]
}