{
  "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,
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    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
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        ],
        "brand_name": [
          "OXYBUTYNIN"
        ],
        "generic_name": [
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        ],
        "manufacturer_name": [
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        ],
        "product_ndc": [
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          "68382-256",
          "68382-257"
        ],
        "product_type": [
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        ],
        "route": [
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        "substance_name": [
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        "rxcui": [
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          "863628",
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          "68382-255-16",
          "68382-255-01",
          "68382-255-05",
          "68382-255-30",
          "68382-255-77",
          "68382-256-14",
          "68382-256-01",
          "68382-256-16",
          "68382-256-05",
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          "68382-256-06",
          "68382-257-14",
          "68382-257-01",
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          "68382-257-06"
        ],
        "is_original_packager": [
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        "unii": [
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        ]
      },
      "product_type": "Drugs",
      "event_id": "93260",
      "recalling_firm": "Zydus Pharmaceuticals (USA) Inc",
      "address_1": "73 Route 31 N",
      "address_2": "",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide.",
      "recall_number": "D-0098-2024",
      "product_description": "Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01.",
      "product_quantity": "",
      "reason_for_recall": "Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.",
      "recall_initiation_date": "20231019",
      "center_classification_date": "20231108",
      "report_date": "20231115",
      "code_info": "M211541, exp. date 10/2024 M211542, exp. date 10/2024 M212746, exp. date 10/2024 M300660, exp. date 12/2024",
      "more_code_info": ""
    }
  ]
}