{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA206880"
        ],
        "brand_name": [
          "LEVETIRACETAM"
        ],
        "generic_name": [
          "LEVETIRACETAM INJECTION"
        ],
        "manufacturer_name": [
          "Dr.Reddy's Laboratories Inc"
        ],
        "product_ndc": [
          "43598-635",
          "43598-636",
          "43598-637"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "LEVETIRACETAM"
        ],
        "rxcui": [
          "1193358",
          "1193360",
          "1193362"
        ],
        "spl_id": [
          "f5cfc6e1-79f3-bd25-5f66-9ea05bc47def"
        ],
        "spl_set_id": [
          "0a9234b7-46b1-8e6c-a992-90f86cfb6e00"
        ],
        "package_ndc": [
          "43598-635-52",
          "43598-635-10",
          "43598-636-52",
          "43598-636-10",
          "43598-637-52",
          "43598-637-10",
          "3435986375"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000008486"
        ],
        "pharm_class_pe": [
          "Decreased Central Nervous System Disorganized Electrical Activity [PE]"
        ],
        "unii": [
          "44YRR34555"
        ],
        "upc": [
          "343598637525"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81441",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0485-2019",
      "product_description": "Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL Infusion bag, Manufactured by: Gland Pharma Limited Hyderabad - 500 043, India Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 UPC 343598637525 ---- NDC 43598-637-52",
      "product_quantity": "2770 bags; 277 selling units",
      "reason_for_recall": "Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL).",
      "recall_initiation_date": "20181026",
      "center_classification_date": "20190211",
      "termination_date": "20230404",
      "report_date": "20190220",
      "code_info": "ABD807, exp 05/2020"
    }
  ]
}