{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Waltham",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078177"
        ],
        "brand_name": [
          "SODIUM CHLORIDE"
        ],
        "generic_name": [
          "SODIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Fresenius Medical Care Renal Therapies Group, LLC"
        ],
        "product_ndc": [
          "49230-300"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "SODIUM CHLORIDE"
        ],
        "rxcui": [
          "1807639"
        ],
        "spl_id": [
          "4e559356-726d-a8d7-e063-6294a90aea68"
        ],
        "spl_set_id": [
          "af5cdf1a-19f4-11e2-892e-0800200c9a66"
        ],
        "package_ndc": [
          "49230-300-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "451W47IQ8X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92403",
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "address_1": "920 Winter St Bld 950",
      "address_2": "N/A",
      "postal_code": "02451-1521",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to 32 clinics in SC, NC and VA.",
      "recall_number": "D-0777-2023",
      "product_description": "Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10",
      "product_quantity": "53,424 bags",
      "reason_for_recall": "Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.",
      "recall_initiation_date": "20230523",
      "center_classification_date": "20230601",
      "termination_date": "20240523",
      "report_date": "20230607",
      "code_info": "Lot # 23AU05030, Exp 01/13/2024; 23AU05035, Exp 01/15/2024"
    }
  ]
}