{
  "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.",
          "McKesson Corporation dba SKY Packaging",
          "Brookfield Pharmaceuticals, LLC.",
          "Novagenix Labs LLC"
        ],
        "product_ndc": [
          "73293-0001",
          "73293-0004",
          "73293-0005",
          "73293-0003",
          "63739-170",
          "71351-021",
          "71351-026",
          "71351-027",
          "71351-023",
          "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",
          "2e9ea4d1-65b6-f07d-e063-6394a90a4b20",
          "470c127d-31e7-0299-e063-6394a90a2ad0",
          "302f313a-e838-a040-e063-6394a90ae806"
        ],
        "spl_set_id": [
          "8ec2d256-fc4f-44f6-bee2-eef2bf3bf580",
          "e1eabd6b-9bb8-646f-e053-2a95a90a7b83",
          "e824ba5b-3289-5ad4-e053-2995a90acc20",
          "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",
          "63739-170-13",
          "63739-170-24",
          "63739-170-27",
          "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",
          "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",
          "0363739170247",
          "0363739170131",
          "0371351026255",
          "0371351021250",
          "0371351023254",
          "0371351027252",
          "0371351021106",
          "0371351027207",
          "0371351021052",
          "0371351026200",
          "0371351023100"
        ],
        "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-0529-2026",
      "product_description": "Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by: McKesson Corporation, dba Sky Packaging, NDC 63739-170-13 (vials), NDC 63739-170-24 (10 count cartons) and NDC 63739-170-27 (25 count cartons); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 71351-021-05 (vials), NDC 71351-021-10 (10 count cartons), NDC 71351-021-25 (25 count cartons); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0001-1 (vials), NDC 84769-0001-2 (10 count carton)",
      "product_quantity": "33,599,925 ampules and 23658125 vials",
      "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"
    }
  ]
}