{
  "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": "Terminated",
      "city": "Durham",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA213238"
        ],
        "brand_name": [
          "GLYCOPYRROLATE"
        ],
        "generic_name": [
          "GLYCOPYRROLATE"
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        "manufacturer_name": [
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        ],
        "product_ndc": [
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          "16729-472",
          "16729-473",
          "16729-474"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "GLYCOPYRROLATE"
        ],
        "rxcui": [
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          "1731582",
          "1731590"
        ],
        "spl_id": [
          "415de5a5-d773-4816-e063-6294a90a6853"
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        "spl_set_id": [
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        ],
        "package_ndc": [
          "16729-471-08",
          "16729-472-08",
          "16729-473-03",
          "16729-474-03",
          "16729-474-05",
          "16729-473-31"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0316729474054",
          "0316729472302",
          "0316729473316",
          "0316729471633",
          "316729473316",
          "316729473033"
        ],
        "unii": [
          "V92SO9WP2I"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91657",
      "recalling_firm": "Accord Healthcare, Inc.",
      "address_1": "1009 Slater Rd Ste 210B",
      "address_2": "N/A",
      "postal_code": "27703-8446",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "United States including Puerto Rico and Canada",
      "recall_number": "D-0398-2023",
      "product_description": "Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA  5mL vial NDC 16729-473-31 UPC 3 16729 47331 6; carton NDC 16729-473-03 UPC 3 16729 47303 3",
      "product_quantity": "3,164 vials",
      "reason_for_recall": "CGMP Deviations: recalling drug products following an FDA inspection.",
      "recall_initiation_date": "20230207",
      "center_classification_date": "20230302",
      "termination_date": "20240422",
      "report_date": "20230308",
      "code_info": "Batches:  R2200259, Exp. Date 2/29/2024, R2200258, Exp. Date 2/29/2024, R2200617, Exp. Date 4/30/2024, R2201308, Exp. Date 8/31/2024",
      "more_code_info": ""
    }
  ]
}