{
  "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": "Irving",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA125544"
        ],
        "brand_name": [
          "INFLECTRA"
        ],
        "generic_name": [
          "INFLIXIMAB-DYYB"
        ],
        "manufacturer_name": [
          "Pfizer Laboratories Div Pfizer Inc"
        ],
        "product_ndc": [
          "0069-0809"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "INFLIXIMAB"
        ],
        "rxcui": [
          "1790541",
          "1790546"
        ],
        "spl_id": [
          "421960f4-55cd-4bf8-9f00-b980b020e7a7"
        ],
        "spl_set_id": [
          "37eaca10-d812-48bc-8b8e-b836bfa9968f"
        ],
        "package_ndc": [
          "0069-0809-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0300690809014"
        ],
        "nui": [
          "N0000175610",
          "N0000175451"
        ],
        "pharm_class_epc": [
          "Tumor Necrosis Factor Blocker [EPC]"
        ],
        "pharm_class_moa": [
          "Tumor Necrosis Factor Receptor Blocking Activity [MoA]"
        ],
        "unii": [
          "B72HH48FLU"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96167",
      "recalling_firm": "McKesson",
      "address_1": "6555 State Highway 161",
      "address_2": "",
      "postal_code": "75039-2402",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide USA",
      "recall_number": "D-0213-2025",
      "product_description": "Inflectra (infliximab-dyyb), For injection, 100mg per vial, packaged in 10 mL single-dose vial, Rx only, Mfd by: CELLTRION, INC, Dist. by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001, NDC 0069-0809-01",
      "product_quantity": "192 vials",
      "reason_for_recall": "cGMP Deviations: Product intended for quarantine was inadvertently distributed.",
      "recall_initiation_date": "20250117",
      "center_classification_date": "20250130",
      "report_date": "20250205",
      "code_info": "Lot# 04647349, Exp Date 5/31/2029",
      "more_code_info": ""
    }
  ]
}