{
  "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": "Ongoing",
      "city": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA202494"
        ],
        "brand_name": [
          "SODIUM BICARBONATE"
        ],
        "generic_name": [
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        ],
        "product_ndc": [
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          "0409-4916"
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        "product_type": [
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        ],
        "route": [
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        "substance_name": [
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        "rxcui": [
          "727995",
          "792582"
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        "spl_id": [
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        "spl_set_id": [
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        "package_ndc": [
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          "0409-4916-14",
          "0409-6637-24",
          "0409-6637-14",
          "00409-6637-14"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8MDF5V39QO"
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      },
      "product_type": "Drugs",
      "event_id": "97364",
      "recalling_firm": "PFIZER INC",
      "address_1": "68 Hudson Blvd E",
      "address_2": "N/A",
      "postal_code": "10001-2188",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-0591-2025",
      "product_description": "Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24.  Case NDC: 00409-6637-14.",
      "product_quantity": "15,750 vials",
      "reason_for_recall": "Lack of Assurance of Sterility.",
      "recall_initiation_date": "20250804",
      "center_classification_date": "20250818",
      "report_date": "20250827",
      "code_info": "Lot #: LH2671, Exp. 11/30/2026"
    }
  ]
}