{
  "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,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Richmond",
      "state": "VA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA021859"
        ],
        "brand_name": [
          "HYLENEX RECOMBINANT"
        ],
        "generic_name": [
          "HYALURONIDASE"
        ],
        "manufacturer_name": [
          "Antares Pharma, Inc."
        ],
        "product_ndc": [
          "18657-117"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "HYALURONIDASE (HUMAN RECOMBINANT)"
        ],
        "rxcui": [
          "630936",
          "630939"
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        "spl_id": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "18657-117-01",
          "18657-117-02",
          "18657-117-04",
          "1000008319",
          "1000008206",
          "1000008205"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175531",
          "M0009499"
        ],
        "pharm_class_epc": [
          "Endoglycosidase [EPC]"
        ],
        "pharm_class_cs": [
          "Glycoside Hydrolases [CS]"
        ],
        "unii": [
          "743QUY4VD8"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95830",
      "recalling_firm": "Mckesson Medical-Surgical Inc. Corporate Office",
      "address_1": "9954 Maryland Drive",
      "address_2": "Deep Run Iii Ste. 4000",
      "postal_code": "23233",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Virgina",
      "recall_number": "D-0116-2025",
      "product_description": "Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares Pharma, Inc., Ewing, NJ  NDC 18657-117-04",
      "product_quantity": "5 cartons/20 units each carton",
      "reason_for_recall": "cGMP Deviations: Temperature excursion",
      "recall_initiation_date": "20240911",
      "center_classification_date": "20241210",
      "termination_date": "20250820",
      "report_date": "20241218",
      "code_info": "Serial # 100000831961 100000820688 100000820689 100000820515",
      "more_code_info": ""
    }
  ]
}