{
  "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": "2026-09-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Morgantown",
      "state": "WV",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203859"
        ],
        "brand_name": [
          "MYCOPHENOLATE MOFETIL"
        ],
        "generic_name": [
          "MYCOPHENOLATE MOFETIL"
        ],
        "manufacturer_name": [
          "Mylan Institutional LLC"
        ],
        "product_ndc": [
          "67457-386"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "MYCOPHENOLATE MOFETIL"
        ],
        "rxcui": [
          "311881"
        ],
        "spl_id": [
          "4c643876-2577-4197-ac9b-81bab65d1362"
        ],
        "spl_set_id": [
          "da02b428-42a4-4007-b0b7-695f2db010f2"
        ],
        "package_ndc": [
          "67457-386-00",
          "67457-386-81"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "9242ECW6R0"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99750",
      "recalling_firm": "Mylan Pharmaceuticals Inc",
      "address_1": "3711 Collins Ferry Rd",
      "address_2": "N/A",
      "postal_code": "26505-2362",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-0830-2026",
      "product_description": "Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81.  Vial Label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-00.",
      "product_quantity": "11,336 units",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20260826",
      "center_classification_date": "20260903",
      "report_date": "20260909",
      "code_info": "Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027",
      "more_code_info": ""
    }
  ]
}