{
  "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 III",
      "openfda": {
        "application_number": [
          "NDA216078"
        ],
        "brand_name": [
          "BENDAMUSTINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "BENDAMUSTINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Corporation"
        ],
        "product_ndc": [
          "10019-079"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "BENDAMUSTINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1726097"
        ],
        "spl_id": [
          "007f13c9-9ca3-45f9-bbae-6806681efd06"
        ],
        "spl_set_id": [
          "766b73e2-49bb-47f9-bbb1-44cfa1a3197e"
        ],
        "package_ndc": [
          "10019-079-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "981Y8SX18M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92887",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "address_2": "N/A",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the U.S.A.",
      "recall_number": "D-1103-2023",
      "product_description": "Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.",
      "product_quantity": "13,502 vials",
      "reason_for_recall": "Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.",
      "recall_initiation_date": "20230814",
      "center_classification_date": "20230824",
      "report_date": "20230830",
      "code_info": "Lots: 3A004A, 3A004B, Exp 12/31/2024; 3B005A, Exp 1/31/2025"
    }
  ]
}