{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Lexington",
      "state": "MA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "BLA022575"
        ],
        "brand_name": [
          "VPRIV"
        ],
        "generic_name": [
          "VELAGLUCERASE ALFA"
        ],
        "manufacturer_name": [
          "Takeda Pharmaceuticals America, Inc."
        ],
        "product_ndc": [
          "54092-701"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "VELAGLUCERASE ALFA"
        ],
        "rxcui": [
          "901808",
          "901812"
        ],
        "spl_id": [
          "27f96d8e-a6e0-4743-a76c-00f979bfb5f7"
        ],
        "spl_set_id": [
          "ca02f7a4-ae4f-43c1-a06a-259fe4fcf9cf"
        ],
        "package_ndc": [
          "54092-701-04"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175820"
        ],
        "pharm_class_epc": [
          "Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]"
        ],
        "unii": [
          "23HYE36B0I"
        ]
      },
      "product_type": "Drugs",
      "event_id": "67690",
      "recalling_firm": "Shire Human Genetic Therapies, Inc.",
      "address_1": "300-400 Shire Way",
      "address_2": "N/A",
      "postal_code": "02421-2101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide including Puerto Rico; Mexico, Columbia",
      "recall_number": "D-1251-2014",
      "product_description": "VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human Genetic Therapies, Inc. 300 Shire Way, Lexington, MA 02421. NDC: 54092-701-04.",
      "product_quantity": "8359 vials",
      "reason_for_recall": "Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.",
      "recall_initiation_date": "20140314",
      "center_classification_date": "20140418",
      "termination_date": "20160831",
      "report_date": "20140430",
      "code_info": "US: Lot #:  FEW13-001, FEW13-002, FED13-006; Expiry: 10/15.  Mexico: Lot #: FED 013-010; Expiry: 10/15.  Columbia: Lot #: FED 013-011; Expiry: 10/15.",
      "more_code_info": ""
    }
  ]
}