{
  "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 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",
          "72572-740-01",
          "72572-740-20"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8MDF5V39QO"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93265",
      "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": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0116-2024",
      "product_description": "8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-4), For Intravenous Use Only, RX Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645; ALSO LABELED 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), c) 20x50 mL Single Dose Vials, (Vial NDC 72572-740-01; Carton NDC 72572-740-20), Rx Only, Mfd for: Civica, Inc., Lehi, Utah, 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.",
      "product_quantity": "355,220 vials",
      "reason_for_recall": "Presence of Particulate Matter: Silicone",
      "recall_initiation_date": "20231018",
      "center_classification_date": "20231122",
      "report_date": "20231129",
      "code_info": "a) P0001429, EXP 11/30/2023 b) P0001900, P0001902, EXP 08/31/2024; P0001903, P0001909, P0001945, EXP 09/30/2024; P0002002, EXP 11/30/2024; P0002052, EXP 12/31/2024 c) P0001912, EXP 08/31/2024",
      "more_code_info": ""
    }
  ]
}