{
  "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": "Northbrook",
      "state": "IL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "NDA050708"
        ],
        "brand_name": [
          "PROGRAF"
        ],
        "generic_name": [
          "TACROLIMUS"
        ],
        "manufacturer_name": [
          "Astellas Pharma US, Inc."
        ],
        "product_ndc": [
          "0469-0607",
          "0469-0617",
          "0469-0657",
          "0469-3016",
          "0469-1230",
          "0469-1330"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TACROLIMUS"
        ],
        "rxcui": [
          "108513",
          "108514",
          "108515",
          "198377",
          "198378",
          "198379",
          "261134",
          "313190",
          "2052605",
          "2052609",
          "2052703",
          "2052704"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
          "7f667de1-9dfa-4bd6-8ba0-15ee2d78873b"
        ],
        "package_ndc": [
          "0469-0607-73",
          "0469-0617-73",
          "0469-0617-11",
          "0469-0657-73",
          "0469-0657-11",
          "0469-3016-01",
          "0469-1230-50",
          "0469-1330-50"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0304690607731",
          "0304690657736",
          "0304691230501",
          "0304691330508",
          "0304690617730",
          "0304693016011"
        ],
        "unii": [
          "WM0HAQ4WNM"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96008",
      "recalling_firm": "Astellas Pharma US Inc.",
      "address_1": "2375 Waterview Dr",
      "address_2": "",
      "postal_code": "60062-6145",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0211-2025",
      "product_description": "Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Product of Japan, Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062, NDC 0469-0607-73.",
      "product_quantity": "14,340 100-count bottles",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules",
      "recall_initiation_date": "20241223",
      "center_classification_date": "20250129",
      "report_date": "20250205",
      "code_info": "Lot# 0E3353D, Exp 03/31/2026",
      "more_code_info": ""
    }
  ]
}