{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Lake Zurich",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA209328"
        ],
        "brand_name": [
          "GLYCOPYRROLATE"
        ],
        "generic_name": [
          "GLYCOPYRROLATE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-578"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "GLYCOPYRROLATE"
        ],
        "rxcui": [
          "238212",
          "1731582",
          "1731590"
        ],
        "spl_id": [
          "779dc924-ecc3-41cc-8cf9-a7354db4f763"
        ],
        "spl_set_id": [
          "54458620-d888-4df6-ae4b-78c3dfed3423"
        ],
        "package_ndc": [
          "63323-578-03",
          "63323-578-01",
          "63323-578-04",
          "63323-578-02",
          "63323-578-07",
          "63323-578-05",
          "63323-578-18",
          "63323-578-20"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363323578046",
          "0363323578039",
          "0363323578077"
        ],
        "unii": [
          "V92SO9WP2I"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99449",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "3 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "60047-8930",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within in the USA",
      "recall_number": "D-0725-2026",
      "product_description": "Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x  5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial:  63323-578-07",
      "product_quantity": "59,425 vials",
      "reason_for_recall": "Presence of Particulate Matter: Hair was found in product",
      "recall_initiation_date": "20260716",
      "center_classification_date": "20260723",
      "report_date": "20260729",
      "code_info": "Lot #: 6134349, 6134620 Exp. Date 11/2026"
    }
  ]
}