{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Gaithersburg",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA761070"
        ],
        "brand_name": [
          "FASENRA"
        ],
        "generic_name": [
          "BENRALIZUMAB"
        ],
        "manufacturer_name": [
          "AstraZeneca Pharmaceuticals LP"
        ],
        "product_ndc": [
          "0310-1730",
          "0310-1830",
          "0310-1745"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "BENRALIZUMAB"
        ],
        "rxcui": [
          "1989104",
          "1989109",
          "2205632",
          "2205634",
          "2679499",
          "2679502"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
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          "0310-1730-85",
          "0310-1830-30",
          "0310-1830-85",
          "0310-1745-01",
          "0310-1745-95"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000193803",
          "N0000193802"
        ],
        "pharm_class_epc": [
          "Interleukin-5 Receptor alpha-directed Cytolytic Antibody [EPC]"
        ],
        "pharm_class_moa": [
          "Interleukin 5 Receptor alpha-directed Antibody Interactions [MoA]"
        ],
        "unii": [
          "71492GE1FX"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97760",
      "recalling_firm": "ASTRAZENECA PHARMACEUTICALS",
      "address_1": "950 Wind River Ln",
      "address_2": "",
      "postal_code": "20878-1974",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide in the U.S",
      "recall_number": "D-0028-2026",
      "product_description": "Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. NDC 0310-1730-30",
      "product_quantity": "916 pre-filled syringes",
      "reason_for_recall": "Lack of Assurance of Sterility:",
      "recall_initiation_date": "20251008",
      "center_classification_date": "20251016",
      "report_date": "20251022",
      "code_info": "Lot YJ0152, Expiry: 01/31/2028.",
      "more_code_info": ""
    }
  ]
}