{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "New Albany",
      "state": "OH",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA075861"
        ],
        "brand_name": [
          "LEVOCARNITINE"
        ],
        "generic_name": [
          "LEVOCARNITINE"
        ],
        "manufacturer_name": [
          "American Regent, Inc."
        ],
        "product_ndc": [
          "0517-1045",
          "0517-1075"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "LEVOCARNITINE"
        ],
        "rxcui": [
          "1791371",
          "2673428"
        ],
        "spl_id": [
          "114eaeda-8965-4c92-a3ff-15021b305464"
        ],
        "spl_set_id": [
          "cc4da2c3-f939-444d-9b5b-a57b6051c190"
        ],
        "package_ndc": [
          "0517-1045-01",
          "0517-1045-05",
          "0517-1075-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "M0003493",
          "N0000175903"
        ],
        "pharm_class_cs": [
          "Carnitine [CS]"
        ],
        "pharm_class_epc": [
          "Carnitine Analog [EPC]"
        ],
        "unii": [
          "0G389FZZ9M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98787",
      "recalling_firm": "American Regent, Inc.",
      "address_1": "6610 New Albany Rd E",
      "address_2": "",
      "postal_code": "43054-8730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-0494-2026",
      "product_description": "Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967.  NDC: 0517-1045-01",
      "product_quantity": "74,040 Single Dose Vials",
      "reason_for_recall": "Labeling: Missing Label",
      "recall_initiation_date": "20260416",
      "center_classification_date": "20260428",
      "report_date": "20260506",
      "code_info": "Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31,  2027",
      "more_code_info": ""
    }
  ]
}