{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "West Columbia",
      "state": "SC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA211222"
        ],
        "brand_name": [
          "STERILE WATER"
        ],
        "generic_name": [
          "STERILE WATER"
        ],
        "manufacturer_name": [
          "Nephron Pharmaceuticals Corporation"
        ],
        "product_ndc": [
          "0487-6105"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "WATER"
        ],
        "spl_id": [
          "39ada97d-53b0-5144-e063-6294a90a91ba"
        ],
        "spl_set_id": [
          "bc04a883-babc-87a6-e053-2995a90a3dfd"
        ],
        "package_ndc": [
          "0487-6105-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0304876105013",
          "304876105013"
        ],
        "unii": [
          "059QF0KO0R"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91449",
      "recalling_firm": "Nephron Sc Inc",
      "address_1": "4500 12th Street Ext",
      "address_2": "N/A",
      "postal_code": "29172-3025",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0178-2023",
      "product_description": "Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street Extension, W. Columbia, SC 29172, NDC 0487-6105-01, UPC 3 04876 10501 3.",
      "product_quantity": "389,730 vials",
      "reason_for_recall": "CGMP Deviations: potential for trace amounts of product carryover.",
      "recall_initiation_date": "20230112",
      "center_classification_date": "20230124",
      "termination_date": "20241011",
      "report_date": "20230201",
      "code_info": "Lots: 124081, 124082, Exp. 04/2023; 224031, Exp. 01/2024",
      "more_code_info": ""
    }
  ]
}