{
  "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": "2026-09-30",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Tehsil Baddi, District Solan",
      "state": "",
      "country": "India",
      "classification": "Class III",
      "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": [
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        "spl_set_id": [
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        "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",
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          "33342-070-07",
          "33342-070-15",
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          "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": [
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          "0333342070074",
          "0333342069078",
          "0333342072078",
          "0333342071071",
          "0333342068071"
        ],
        "nui": [
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        "pharm_class_epc": [
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        ],
        "unii": [
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        ]
      },
      "product_type": "Drugs",
      "event_id": "99773",
      "recalling_firm": "Macleods Pharmaceuticals Limited",
      "address_1": "Village Theda",
      "address_2": "Post Office Lodhimajra",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0867-2026",
      "product_description": "Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-068-07.",
      "product_quantity": "22,032 30-count bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.",
      "recall_initiation_date": "20260827",
      "center_classification_date": "20260922",
      "report_date": "20260930",
      "code_info": "Lot: BOB22321A, Exp 07-31-2027.",
      "more_code_info": ""
    }
  ]
}