{
  "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,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Cambridge",
      "state": "MA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "BLA125291"
        ],
        "brand_name": [
          "LUMIZYME"
        ],
        "generic_name": [
          "ALGLUCOSIDASE ALFA"
        ],
        "manufacturer_name": [
          "Genzyme Corporation"
        ],
        "product_ndc": [
          "58468-0160"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
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        ],
        "rxcui": [
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          "993072"
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        "spl_set_id": [
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        "package_ndc": [
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          "58468-0160-2"
        ],
        "is_original_packager": [
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        ],
        "nui": [
          "M0000794",
          "N0000175821"
        ],
        "pharm_class_cs": [
          "alpha-Glucosidases [CS]"
        ],
        "pharm_class_epc": [
          "Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC]"
        ],
        "unii": [
          "DTI67O9503"
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      },
      "product_type": "Drugs",
      "event_id": "72929",
      "recalling_firm": "Genzyme Corporation",
      "address_1": "500 Kendall Street",
      "address_2": "675 West Kendall/55 Cambridge Parkway",
      "postal_code": "02142-1108",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "TN",
      "recall_number": "D-0799-2016",
      "product_description": "Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1",
      "product_quantity": "24 vials",
      "reason_for_recall": "Labeling: Incorrect or Missing Lot and/or Exp Date",
      "recall_initiation_date": "20151208",
      "center_classification_date": "20160331",
      "termination_date": "20160801",
      "report_date": "20160406",
      "code_info": "Lot # C5370C02; Exp. 02/18"
    }
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}