{
  "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": "Terminated",
      "city": "Baltimore",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206799"
        ],
        "brand_name": [
          "VORICONAZOLE"
        ],
        "generic_name": [
          "VORICONAZOLE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals,Inc."
        ],
        "product_ndc": [
          "43386-038"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VORICONAZOLE"
        ],
        "rxcui": [
          "465355"
        ],
        "spl_id": [
          "9b8865b7-cdc3-4505-b9ba-b3ab1bf909d6"
        ],
        "spl_set_id": [
          "e37525e8-afb4-4583-b2de-af4aab9040d7"
        ],
        "package_ndc": [
          "43386-038-60"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175487",
          "M0002083",
          "N0000182141",
          "N0000182140",
          "N0000185504"
        ],
        "pharm_class_epc": [
          "Azole Antifungal [EPC]"
        ],
        "pharm_class_cs": [
          "Azoles [CS]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 3A4 Inhibitors [MoA]",
          "Cytochrome P450 2C19 Inhibitors [MoA]",
          "Cytochrome P450 2C9 Inhibitors [MoA]"
        ],
        "unii": [
          "JFU09I87TR"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93934",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "Harborplace Tower",
      "address_2": "111 S Calvert St Fl 21st",
      "postal_code": "21202-6174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "OH, IL, NJ",
      "recall_number": "D-0337-2024",
      "product_description": "Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously for 1 minute. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202. NDC: 43386-038-60.",
      "product_quantity": "N/A",
      "reason_for_recall": "Labeling: Incorrect or Missing Package Insert",
      "recall_initiation_date": "20240205",
      "center_classification_date": "20240216",
      "termination_date": "20241227",
      "report_date": "20240228",
      "code_info": "Lot#: S200756; Exp. 10/2024 Lot#: S300218; Exp. 04/2025 Lot#: S300633; Exp. 09/2025"
    }
  ]
}