{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
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  "results": [
    {
      "status": "Terminated",
      "city": "North Wales",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090308"
        ],
        "brand_name": [
          "CLOZAPINE"
        ],
        "generic_name": [
          "CLOZAPINE"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
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          "0093-5416",
          "0093-5417",
          "0093-5419",
          "0093-5377"
        ],
        "product_type": [
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        ],
        "route": [
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        ],
        "substance_name": [
          "CLOZAPINE"
        ],
        "rxcui": [
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          "476179",
          "721773",
          "996921",
          "1006801"
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          "0093-5417-01",
          "0093-5417-19",
          "0093-5417-84",
          "0093-5419-01",
          "0093-5419-19",
          "0093-5419-84",
          "0093-5376-01",
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          "0093-5377-01",
          "0093-5377-19",
          "0093-5377-84"
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        "is_original_packager": [
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        "nui": [
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        ],
        "pharm_class_epc": [
          "Atypical Antipsychotic [EPC]"
        ],
        "unii": [
          "J60AR2IKIC"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81068",
      "recalling_firm": "Teva Pharmaceuticals USA",
      "address_1": "1090 Horsham Rd",
      "address_2": "",
      "postal_code": "19454-1505",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed nationwide in the USA",
      "recall_number": "D-0001-2019",
      "product_description": "Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA  19454, NDC 0093-5416-01  Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.",
      "product_quantity": "313 bottles",
      "reason_for_recall": "Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.",
      "recall_initiation_date": "20180921",
      "center_classification_date": "20181001",
      "termination_date": "20190501",
      "report_date": "20181010",
      "code_info": "Lot #: 34034024B, Exp 02/20",
      "more_code_info": ""
    }
  ]
}