{
  "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": "Warren",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA218922"
        ],
        "brand_name": [
          "NILOTINIB"
        ],
        "generic_name": [
          "NILOTINIB"
        ],
        "manufacturer_name": [
          "Cipla USA Inc."
        ],
        "product_ndc": [
          "69097-030",
          "69097-031",
          "69097-032"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NILOTINIB"
        ],
        "rxcui": [
          "2715459",
          "2715469",
          "2715473"
        ],
        "spl_id": [
          "d748f03e-56ba-48e2-ae13-e8e74fac55e7"
        ],
        "spl_set_id": [
          "e27c3e09-bc4f-4f01-be05-1c43ac72285d"
        ],
        "package_ndc": [
          "69097-030-08",
          "69097-030-16",
          "69097-030-63",
          "69097-031-17",
          "69097-031-56",
          "69097-031-74",
          "69097-031-76",
          "69097-031-73",
          "69097-031-91",
          "69097-032-17",
          "69097-032-56",
          "69097-032-74",
          "69097-032-76",
          "69097-032-73",
          "69097-032-91"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175605",
          "N0000020009",
          "N0000187062",
          "N0000182137",
          "N0000187064",
          "N0000187063",
          "N0000191272",
          "N0000185503"
        ],
        "pharm_class_epc": [
          "Kinase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Bcr-Abl Tyrosine Kinase Inhibitors [MoA]",
          "Cytochrome P450 2C8 Inhibitors [MoA]",
          "Cytochrome P450 2D6 Inhibitors [MoA]",
          "Cytochrome P450 2B6 Inducers [MoA]",
          "Cytochrome P450 2C8 Inducers [MoA]",
          "UGT1A1 Inhibitors [MoA]",
          "P-Glycoprotein Inhibitors [MoA]"
        ],
        "unii": [
          "F41401512X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98452",
      "recalling_firm": "Cipla USA, Inc.",
      "address_1": "10 Independence Blvd",
      "address_2": "N/A",
      "postal_code": "07059-2730",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.A. Nationwide",
      "recall_number": "D-0381-2026",
      "product_description": "Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17",
      "product_quantity": "271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.",
      "recall_initiation_date": "20260218",
      "center_classification_date": "20260303",
      "report_date": "20260311",
      "code_info": "Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027"
    }
  ]
}