{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA022458"
        ],
        "brand_name": [
          "ELELYSO"
        ],
        "generic_name": [
          "TALIGLUCERASE ALFA"
        ],
        "manufacturer_name": [
          "Pfizer Laboratories Div Pfizer Inc"
        ],
        "product_ndc": [
          "0069-0106"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "TALIGLUCERASE ALFA"
        ],
        "rxcui": [
          "1292879",
          "1292881"
        ],
        "spl_id": [
          "d7eb51c8-fe18-46f2-8d97-eaa343ec8821"
        ],
        "spl_set_id": [
          "fa3cbd5d-677c-4b19-9032-d9182cb69a83"
        ],
        "package_ndc": [
          "0069-0106-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175820",
          "M0009360"
        ],
        "pharm_class_epc": [
          "Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]"
        ],
        "pharm_class_cs": [
          "Glucosylceramidase [CS]"
        ],
        "unii": [
          "0R4NLX88O4"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81050",
      "recalling_firm": "Pfizer Inc.",
      "address_1": "235 E 42nd St",
      "address_2": "",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.A. nationwide.  The following countries received product from Lot S91616: Albania, South Africa, Israel, Afghanistan, Rwanda, Botswana, Zimbabwe and Iraq as part of the Compassionate Use Program.",
      "recall_number": "D-0005-2019",
      "product_description": "Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC  0069-0106-01",
      "product_quantity": "12,416 vials",
      "reason_for_recall": "Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection.  The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.",
      "recall_initiation_date": "20180919",
      "center_classification_date": "20181002",
      "termination_date": "20200626",
      "report_date": "20181010",
      "code_info": "Lot S91616",
      "more_code_info": ""
    }
  ]
}