{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "150105",
      "product_res_number": "Z-0078-2017",
      "event_date_initiated": "2015-09-21",
      "event_date_created": "2016-10-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-10-17",
      "res_event_number": "75350",
      "product_code": "NAW",
      "product_description": "TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION\nTheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.",
      "code_info": "Lot 1599211, Expiry Date: 18SEP2015 (12 days after calibration)",
      "firm_fei_number": "3002124543",
      "recalling_firm": "Biocompatibles U.K., Ltd.",
      "address_1": "Bortoli House Weydon Lane Old Farnham Lane",
      "city": "Farnham",
      "country": "United Kingdom",
      "additional_info_contact": "Janet Bukovcan\n613-801-1848",
      "reason_for_recall": "One mislabeled dose of TheraSphere Y-90 Glass Microspheres, which was shipped to Hong Kong (total radioactivity incorrect).  The product ws labeled as 10 GBq and the actual does was 5 GBq.",
      "root_cause_description": "Packaging",
      "action": "Biocompatibles UK Ltd sent an Urgent Field Safety Notice dated September 21, 2015, to all affected customers.  The firm did not request return or destruction of the product.  Customers with questions were instructed to call 613-410-1870.\nFor questions regarding this recall call 613-801-1848.",
      "product_quantity": "64 doses",
      "distribution_pattern": "Worldwide Distribution - US to CA, FL, IL, WI, IN, OR, PA, MA, NY, KY, TX, MI, MD, NV, WA, OH, MN, and Internationally to Germany, Turkey, Hong Kong, Italy, Portugal",
      "openfda": {
        "pma_number": [
          "P990065",
          "P200029"
        ],
        "registration_number": [
          "2134265",
          "2124215",
          "3009088444",
          "3005579300",
          "3013070673",
          "8022247",
          "1450662",
          "3012690638"
        ],
        "fei_number": [
          "3002095335",
          "2124215",
          "3009088444",
          "3005579300",
          "3001092088",
          "3013070673",
          "1450662",
          "3012690638"
        ],
        "device_name": "Microspheres Radionuclide",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}