{
  "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": "Lenoir",
      "state": "NC",
      "country": "United States",
      "classification": "Class I",
      "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",
          "51754-5001-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8MDF5V39QO"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91197",
      "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": "Press Release",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0079-2023",
      "product_description": "8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1.",
      "product_quantity": "489,600 vials",
      "reason_for_recall": "Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.",
      "recall_initiation_date": "20221128",
      "center_classification_date": "20221213",
      "termination_date": "20251010",
      "report_date": "20221221",
      "code_info": "Lots: P0001178 Exp. 05/2023; P0001298, P0001301, P0001313, P0001314, P0001317 Exp. 08/2023; P0001330, P0001464  Exp. 09/2023; P0001442 Exp. 11/2023;  P0001467, P0001472, P0001486, P0001532 Exp. 12/2023."
    }
  ]
}