{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Pulaski",
      "state": "TN",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA078503"
        ],
        "brand_name": [
          "OXYBUTYNIN CHLORIDE"
        ],
        "generic_name": [
          "OXYBUTYNIN CHLORIDE"
        ],
        "manufacturer_name": [
          "AvKARE"
        ],
        "product_ndc": [
          "42291-633",
          "42291-634",
          "42291-635"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "OXYBUTYNIN CHLORIDE"
        ],
        "rxcui": [
          "863619",
          "863628",
          "863636"
        ],
        "spl_id": [
          "46143c62-4276-2b49-e063-6294a90ae1aa"
        ],
        "spl_set_id": [
          "94471401-a516-0fe7-ec9c-447dd2bee972"
        ],
        "package_ndc": [
          "42291-633-01",
          "42291-633-50",
          "42291-634-01",
          "42291-634-50",
          "42291-635-01"
        ],
        "original_packager_product_ndc": [
          "62175-270",
          "62175-271",
          "62175-272"
        ],
        "upc": [
          "0342291635012",
          "0342291633018",
          "0342291634503",
          "0342291633506"
        ],
        "unii": [
          "L9F3D9RENQ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "82296",
      "recalling_firm": "AVKARE Inc.",
      "address_1": "615 N 1st St",
      "address_2": "N/A",
      "postal_code": "38478-2403",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide.",
      "recall_number": "D-0990-2019",
      "product_description": "Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478",
      "product_quantity": "a) 2947 and b) 3379",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20190301",
      "center_classification_date": "20190311",
      "termination_date": "20200114",
      "report_date": "20190320",
      "code_info": "Lots: a) 22738 Exp. 07/2020 and b) 22739 Exp. 07/2020"
    }
  ]
}