{
  "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": "Ongoing",
      "city": "Lenoir",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA211091"
        ],
        "brand_name": [
          "SODIUM BICARBONATE"
        ],
        "generic_name": [
          "SODIUM BICARBONATE"
        ],
        "manufacturer_name": [
          "Exela Pharma Sciences, LLC"
        ],
        "product_ndc": [
          "51754-5001",
          "51754-5011",
          "51754-5002",
          "51754-5012"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "SODIUM BICARBONATE"
        ],
        "rxcui": [
          "807284",
          "1868486",
          "1923484",
          "2198792"
        ],
        "spl_id": [
          "4da0ba66-756d-4b4d-8018-81ca16578ef1"
        ],
        "spl_set_id": [
          "e9698a4f-1a95-4f28-a945-e8009d1d6dd4"
        ],
        "package_ndc": [
          "51754-5001-5",
          "51754-5001-4",
          "51754-5011-4",
          "51754-5002-5",
          "51754-5012-4",
          "51754-5012-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8MDF5V39QO"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97348",
      "recalling_firm": "Exela Pharma Sciences LLC",
      "address_1": "1245 Blowing Rock Blvd",
      "address_2": "N/A",
      "postal_code": "28645-3618",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0620-2025",
      "product_description": "4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)",
      "product_quantity": "N/A",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.",
      "recall_initiation_date": "20250730",
      "center_classification_date": "20250905",
      "report_date": "20250917",
      "code_info": "Lot # 10004077, Exp. 02/28/2026"
    }
  ]
}