{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA076255"
        ],
        "brand_name": [
          "OLANZAPINE"
        ],
        "generic_name": [
          "OLANZAPINE"
        ],
        "manufacturer_name": [
          "Dr. Reddy's Laboratories Ltd."
        ],
        "product_ndc": [
          "55111-163"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "OLANZAPINE"
        ],
        "rxcui": [
          "200034"
        ],
        "spl_id": [
          "ba26436d-7009-476f-23b0-45676a0e7805"
        ],
        "spl_set_id": [
          "9a57a63e-f856-aafa-037a-c08f2fea6496"
        ],
        "package_ndc": [
          "55111-163-30",
          "55111-163-01",
          "55111-163-05",
          "55111-163-79",
          "55111-163-78"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175430"
        ],
        "pharm_class_epc": [
          "Atypical Antipsychotic [EPC]"
        ],
        "unii": [
          "N7U69T4SZR"
        ]
      },
      "product_type": "Drugs",
      "event_id": "75442",
      "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": "US Nationwide",
      "recall_number": "D-0468-2017",
      "product_description": "Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30",
      "product_quantity": "5,904 bottles",
      "reason_for_recall": "Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.",
      "recall_initiation_date": "20161013",
      "center_classification_date": "20170203",
      "termination_date": "20170724",
      "report_date": "20170215",
      "code_info": "C500202"
    }
  ]
}