{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Jecheon",
      "state": "N/A",
      "country": "Korea (the Republic of)",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA212821"
        ],
        "brand_name": [
          "LIDOCAINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "LIDOCAINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Huons Co., Ltd.",
          "Brookfield Pharmaceuticals, LLC.",
          "Precision Dose, Inc.",
          "Novagenix Labs LLC"
        ],
        "product_ndc": [
          "73293-0001",
          "73293-0004",
          "73293-0005",
          "73293-0003",
          "71351-021",
          "71351-026",
          "71351-027",
          "71351-023",
          "68094-081",
          "84769-0001",
          "84769-0002"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "LIDOCAINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1010033",
          "1010671",
          "1737566",
          "1737761"
        ],
        "spl_id": [
          "4711fd53-dad3-f117-e063-6394a90a8d3d",
          "470c127d-31e7-0299-e063-6394a90a2ad0",
          "4711ae97-ff32-948e-e063-6394a90ae40d",
          "302f313a-e838-a040-e063-6394a90ae806"
        ],
        "spl_set_id": [
          "8ec2d256-fc4f-44f6-bee2-eef2bf3bf580",
          "e824ba5b-3289-5ad4-e053-2995a90acc20",
          "27b6ef54-a093-2bef-e063-6394a90a7912",
          "7567ffb5-953a-4be9-9a02-c5a50dcd9306"
        ],
        "package_ndc": [
          "73293-0004-1",
          "73293-0004-2",
          "73293-0005-1",
          "73293-0005-2",
          "73293-0001-1",
          "73293-0001-2",
          "73293-0003-1",
          "73293-0003-2",
          "71351-026-20",
          "71351-026-25",
          "71351-027-20",
          "71351-027-25",
          "71351-021-05",
          "71351-021-10",
          "71351-021-25",
          "71351-023-05",
          "71351-023-10",
          "71351-023-25",
          "68094-081-01",
          "68094-081-25",
          "84769-0001-1",
          "84769-0001-2",
          "84769-0002-1",
          "84769-0002-2"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0373293000317",
          "0373293000522",
          "0373293000119",
          "0373293000416",
          "0373293000423",
          "0373293000126",
          "0373293000324",
          "0373293000515",
          "0371351026255",
          "0371351021250",
          "0371351023254",
          "0371351027252",
          "0371351021106",
          "0371351027207",
          "0371351021052",
          "0371351026200",
          "0371351023100",
          "0368094081252",
          "0368094081016"
        ],
        "unii": [
          "V13007Z41A"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98724",
      "recalling_firm": "Huons Co., Ltd.",
      "address_1": "100 Bio-Valley-Ro",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "USA Nationwide.",
      "recall_number": "D-0532-2026",
      "product_description": "Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton)",
      "product_quantity": "N/A",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260402",
      "center_classification_date": "20260515",
      "report_date": "20260422",
      "code_info": "All lots within expiry"
    }
  ]
}