{
  "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": [
          "ANDA206171"
        ],
        "brand_name": [
          "SODIUM CHLORIDE"
        ],
        "generic_name": [
          "SODIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Spectra Medical Deviecs, LLC"
        ],
        "product_ndc": [
          "65282-1505",
          "65282-1510"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "SODIUM CHLORIDE"
        ],
        "rxcui": [
          "1807637",
          "1807646"
        ],
        "spl_id": [
          "447bf261-1a3a-2da1-e063-6394a90a7537"
        ],
        "spl_set_id": [
          "7e316d21-d6ad-4976-bd90-268fd7e51361"
        ],
        "package_ndc": [
          "65282-1510-1",
          "65282-1505-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "451W47IQ8X"
        ]
      },
      "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-0531-2026",
      "product_description": "0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.",
      "product_quantity": "7,120,750 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"
    }
  ]
}