{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Shenzhen",
      "state": "",
      "country": "China",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA202957"
        ],
        "brand_name": [
          "HEPARIN SODIUM"
        ],
        "generic_name": [
          "HEPARIN SODIUM"
        ],
        "manufacturer_name": [
          "Hepalink USA Inc."
        ],
        "product_ndc": [
          "81952-111",
          "81952-113",
          "81952-116",
          "81952-112",
          "81952-115",
          "81952-114"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "HEPARIN SODIUM"
        ],
        "rxcui": [
          "1361226",
          "1361574",
          "1361615",
          "1362831",
          "1658647"
        ],
        "spl_id": [
          "2e8e07a4-763e-79e5-e063-6394a90a7619"
        ],
        "spl_set_id": [
          "c4c6bc1f-e0c7-fd0d-e053-2995a90abdef"
        ],
        "package_ndc": [
          "81952-113-01",
          "81952-113-06",
          "81952-113-03",
          "81952-113-08",
          "81952-116-01",
          "81952-116-06",
          "81952-112-01",
          "81952-112-06",
          "81952-112-04",
          "81952-112-09",
          "81952-112-05",
          "81952-112-10",
          "81952-111-01",
          "81952-111-06",
          "81952-115-02",
          "81952-115-07",
          "81952-114-04",
          "81952-114-09",
          "81942-111-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0381952113018",
          "0381952115074",
          "0381952116019",
          "0381952112103",
          "0381952116064",
          "0381952112059",
          "0381952114091",
          "0381952113063",
          "0381952113032",
          "0381952114046",
          "0381952112042",
          "0381952112097",
          "0381952113087",
          "0381952112066",
          "0381952111069"
        ],
        "unii": [
          "ZZ45AB24CA"
        ]
      },
      "product_type": "Drugs",
      "event_id": "100049",
      "recalling_firm": "Shenzhen Techdow Pharmaceutical Co., Ltd.",
      "address_1": "19 Gaoxinzhongyi Road",
      "address_2": "Nanshan District",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0050-2027",
      "product_description": "Heparin Sodium Injection, USP, 5,000 USP Units/mL, 1mL Multi dose vial x 25 vials per carton, Distributed by: Hepalink USA Inc., Langhome, PA 19047-1885.  Carton NDC: NDC 81952-111-06, Vial NDC: 81942-111-01",
      "product_quantity": "251,000 1 mL multidose vials",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20261001",
      "center_classification_date": "20261016",
      "report_date": "20261028",
      "code_info": "Lot# CU03232A, Exp 1/31/2028",
      "more_code_info": ""
    }
  ]
}