{
  "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": "Plainsboro",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA202862"
        ],
        "brand_name": [
          "OLANZAPINE"
        ],
        "generic_name": [
          "OLANZAPINE"
        ],
        "manufacturer_name": [
          "Macleods Pharmaceuticals Limited"
        ],
        "product_ndc": [
          "33342-067",
          "33342-068",
          "33342-069",
          "33342-070",
          "33342-071",
          "33342-072"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "OLANZAPINE"
        ],
        "rxcui": [
          "200034",
          "283639",
          "312077",
          "312078",
          "312079",
          "314154"
        ],
        "spl_id": [
          "2b861570-6b18-4b2b-89aa-29ebde7770f5"
        ],
        "spl_set_id": [
          "8e095987-bdea-42f2-9550-c7155cf07d30"
        ],
        "package_ndc": [
          "33342-067-07",
          "33342-067-44",
          "33342-067-12",
          "33342-067-11",
          "33342-068-07",
          "33342-068-44",
          "33342-068-12",
          "33342-068-11",
          "33342-069-07",
          "33342-069-44",
          "33342-069-12",
          "33342-069-11",
          "33342-070-07",
          "33342-070-15",
          "33342-070-12",
          "33342-070-44",
          "33342-070-11",
          "33342-071-07",
          "33342-071-15",
          "33342-071-12",
          "33342-071-44",
          "33342-071-11",
          "33342-072-07",
          "33342-072-15",
          "33342-072-12",
          "33342-072-44",
          "33342-072-11"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0333342067074",
          "0333342070074",
          "0333342069078",
          "0333342072078",
          "0333342071071",
          "0333342068071"
        ],
        "nui": [
          "N0000175430"
        ],
        "pharm_class_epc": [
          "Atypical Antipsychotic [EPC]"
        ],
        "unii": [
          "N7U69T4SZR"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89607",
      "recalling_firm": "Macleods Pharma Usa Inc",
      "address_1": "666 Plainsboro Rd Bldg 200 Ste 230",
      "address_2": "",
      "postal_code": "08536-0009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0639-2022",
      "product_description": "Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-07.",
      "product_quantity": "3672 bottles",
      "reason_for_recall": "cGmp Deviations",
      "recall_initiation_date": "20220216",
      "center_classification_date": "20220228",
      "termination_date": "20231016",
      "report_date": "20220309",
      "code_info": "Lot #: BOB42029A, BOB4202B, Exp. Date 09/2022",
      "more_code_info": ""
    }
  ]
}