{
  "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": "Completed",
      "city": "Pulaski",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA202675"
        ],
        "brand_name": [
          "GLYCOPYRROLATE"
        ],
        "generic_name": [
          "GLYCOPYRROLATE"
        ],
        "manufacturer_name": [
          "AvPAK"
        ],
        "product_ndc": [
          "50268-363"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "GLYCOPYRROLATE"
        ],
        "rxcui": [
          "197738"
        ],
        "spl_id": [
          "2f8b2a36-ac60-7762-e063-6294a90ae573"
        ],
        "spl_set_id": [
          "bd497783-e2d1-130c-e053-2995a90a7fb9"
        ],
        "package_ndc": [
          "50268-363-11",
          "50268-363-15"
        ],
        "original_packager_product_ndc": [
          "13107-014"
        ],
        "unii": [
          "V92SO9WP2I"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91390",
      "recalling_firm": "AVKARE LLC",
      "address_1": "615 N 1st St",
      "address_2": "",
      "postal_code": "38478-2403",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0091-2023",
      "product_description": "Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15",
      "product_quantity": "1237 cartons",
      "reason_for_recall": "Failed impurities/degradation specifications: Out of specification for unknown impurities.",
      "recall_initiation_date": "20221222",
      "center_classification_date": "20221228",
      "report_date": "20230104",
      "code_info": "Lot#: 43313, 43342, Exp 12/2023",
      "more_code_info": ""
    }
  ]
}