{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206547"
        ],
        "brand_name": [
          "IMATINIB"
        ],
        "generic_name": [
          "IMATINIB"
        ],
        "manufacturer_name": [
          "Dr.Reddy's Laboratories Inc"
        ],
        "product_ndc": [
          "43598-344",
          "43598-345"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "IMATINIB MESYLATE"
        ],
        "rxcui": [
          "403878",
          "403879"
        ],
        "spl_id": [
          "38a9944b-db90-72f2-3f0b-7767da490ae2"
        ],
        "spl_set_id": [
          "559dd8e5-11f9-70cd-3fb0-9f9eb8484a37"
        ],
        "package_ndc": [
          "43598-344-30",
          "43598-344-90",
          "43598-344-10",
          "43598-344-31",
          "43598-345-30",
          "43598-345-90",
          "43598-345-05",
          "43598-345-31"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8A1O1M485B"
        ]
      },
      "product_type": "Drugs",
      "event_id": "87339",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0287-2021",
      "product_description": "Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90); and b) For Institutional Use Only 30-count (3 x 10 unit-dose) tablets per carton (NDC 43598-344-31); Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540; Made in India.",
      "product_quantity": "a) 1350 bottles; b) 147 cartons",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20210217",
      "center_classification_date": "20210224",
      "termination_date": "20221221",
      "report_date": "20210303",
      "code_info": "Lot #: a) H2000206, Exp 06/22; b) H2000138, Exp 06/22"
    }
  ]
}