{
  "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": "Completed",
      "city": "Deerfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078287"
        ],
        "brand_name": [
          "ONDANSETRON HYDROCHLORIDE"
        ],
        "generic_name": [
          "ONDANSETRON HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Corporation"
        ],
        "product_ndc": [
          "36000-012",
          "36000-013"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ONDANSETRON HYDROCHLORIDE"
        ],
        "rxcui": [
          "283504",
          "1740467"
        ],
        "spl_id": [
          "f917f6a4-bb84-46ed-ba13-68e4c01097e6"
        ],
        "spl_set_id": [
          "729d865f-d84a-495e-9456-4bceebb6e03f"
        ],
        "package_ndc": [
          "36000-012-25",
          "36000-013-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0336000012256"
        ],
        "unii": [
          "NMH84OZK2B"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93359",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "address_2": "",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0146-2024",
      "product_description": "Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA.  Manufactured by: Baxter Pharmaceuticals India Private Ltd, Ahmedabad 382213, India. NDC 36000-012-25",
      "product_quantity": "6,022,675 vials",
      "reason_for_recall": "Failed pH Specifications",
      "recall_initiation_date": "20231114",
      "center_classification_date": "20231207",
      "report_date": "20231213",
      "code_info": "Lot # A0E0959A, A0E0961A, A0E1015A, A0E1020A, Exp. Date 30-Nov-23; A0F0016A, Exp. Date 31-Dec-23; A0F0260A, A0F0261A, A0F0262A, Exp. Date 29-Feb-24; A0F0414A, A0F0415A, A0F0416A, A0F0417A, A0F0418A, Exp. Date 30-Apr-24; A0F0503A, Exp. Date 31-May-24,  A0F0533A, A0F0534A, A0F0535A, A0F0536A, A0F0537A, A0F0540A, A0F0541A, Exp. Date 30-Jun-24; A0F0573A, A0F0574A, A0F0575A, A0F0592A, Exp. Date 31-Jul-24; A0F0596A, A0F0599A, Exp. Date 31-Aug-24 ; A0F0676A, 31-Oct-24.",
      "more_code_info": ""
    }
  ]
}