{
  "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": [
          "ANDA212822"
        ],
        "brand_name": [
          "BUPIVACAINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "BUPIVACAINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Huons Co., Ltd.",
          "Brookfield Pharmaceuticals, LLC."
        ],
        "product_ndc": [
          "73293-0002",
          "71351-022"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBARACHNOID"
        ],
        "substance_name": [
          "BUPIVACAINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1724784"
        ],
        "spl_id": [
          "2e641a0d-4d42-e7cd-e063-6394a90a47d4",
          "484033d6-ca7d-f0fd-e063-6294a90a7890"
        ],
        "spl_set_id": [
          "2dc693df-3218-4a90-b3f7-21e80966a851",
          "e8b32972-6984-4f1c-e053-2995a90a3277"
        ],
        "package_ndc": [
          "73293-0002-1",
          "73293-0002-2",
          "71351-022-02",
          "71351-022-50",
          "71351-022-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0373293000218",
          "0371351022509",
          "0371351022028",
          "0371351022103"
        ],
        "unii": [
          "7TQO7W3VT8"
        ]
      },
      "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-0530-2026",
      "product_description": "Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule),  NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules)",
      "product_quantity": "3,260,170 ampules",
      "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"
    }
  ]
}