{
  "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": "Terminated",
      "city": "Durham",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA213238"
        ],
        "brand_name": [
          "GLYCOPYRROLATE"
        ],
        "generic_name": [
          "GLYCOPYRROLATE"
        ],
        "manufacturer_name": [
          "Accord Healthcare, Inc.,"
        ],
        "product_ndc": [
          "16729-471",
          "16729-472",
          "16729-473",
          "16729-474"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "GLYCOPYRROLATE"
        ],
        "rxcui": [
          "238212",
          "1731582",
          "1731590"
        ],
        "spl_id": [
          "415de5a5-d773-4816-e063-6294a90a6853"
        ],
        "spl_set_id": [
          "871797f0-697a-4a29-a37b-d06219e8f266"
        ],
        "package_ndc": [
          "16729-471-08",
          "16729-472-08",
          "16729-473-03",
          "16729-474-03",
          "16729-474-05",
          "16729-471-63"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0316729474054",
          "0316729472302",
          "0316729473316",
          "0316729471633",
          "316729471633",
          "316729471084"
        ],
        "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-0396-2023",
      "product_description": "Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 1 ml vial NDC 16729-471-63 UPC 3 16729 47163 3; 25 x 1 mL  carton NDC 16729-471-08 UPC 3 16729 47108 4",
      "product_quantity": "23,814 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:  R2200436, Exp. Date 1/31/2024, R2200159, Exp. Date 1/31/2024, R2200166, Exp. Date 1/31/2024, R2200618, Exp. Date 4/30/2024, R2201290, Exp. Date 8/31/2024, R2201324, Exp. Date 8/31/2024",
      "more_code_info": ""
    }
  ]
}