{
  "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": "Deerfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA050718"
        ],
        "brand_name": [
          "DOXIL"
        ],
        "generic_name": [
          "DOXORUBICIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Baxter Healthcare Company"
        ],
        "product_ndc": [
          "0338-0063",
          "0338-0067"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "DOXORUBICIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "1790115",
          "1790127",
          "1790128",
          "1790131"
        ],
        "spl_id": [
          "15bd5c62-3eb4-464f-b446-76ab04fa1ab4"
        ],
        "spl_set_id": [
          "1c153e9e-4cf2-4ac7-9cf9-16f9b48d7dce"
        ],
        "package_ndc": [
          "0338-0063-01",
          "0338-0067-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "82F2G7BL4E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93201",
      "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 USA",
      "recall_number": "D-0048-2024",
      "product_description": "Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015.  NDC 0338-0067-01",
      "product_quantity": "472 vials",
      "reason_for_recall": "CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.",
      "recall_initiation_date": "20230824",
      "center_classification_date": "20231017",
      "termination_date": "20251222",
      "report_date": "20231025",
      "code_info": "Lot# MKZSU02, Exp 6/30/2024"
    }
  ]
}