{
  "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": [
          "ANDA078181"
        ],
        "brand_name": [
          "GLIMEPIRIDE"
        ],
        "generic_name": [
          "GLIMEPIRIDE"
        ],
        "manufacturer_name": [
          "Accord Healthcare Inc"
        ],
        "product_ndc": [
          "16729-001",
          "16729-002",
          "16729-003"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "GLIMEPIRIDE"
        ],
        "rxcui": [
          "199245",
          "199246",
          "199247"
        ],
        "spl_id": [
          "415deb6c-47dc-ed2a-e063-6394a90a66fa"
        ],
        "spl_set_id": [
          "9b74fbac-9e04-4927-9981-1e3dace89c6d"
        ],
        "package_ndc": [
          "16729-001-01",
          "16729-001-16",
          "16729-001-17",
          "16729-002-01",
          "16729-002-16",
          "16729-002-17",
          "16729-003-01",
          "16729-003-16",
          "16729-003-17"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0316729003018",
          "0316729002011",
          "316729001014",
          "316729001168"
        ],
        "nui": [
          "N0000175608",
          "M0020795"
        ],
        "pharm_class_epc": [
          "Sulfonylurea [EPC]"
        ],
        "pharm_class_cs": [
          "Sulfonylurea Compounds [CS]"
        ],
        "unii": [
          "6KY687524K"
        ]
      },
      "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-0393-2023",
      "product_description": "Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle  NDC 16729-001-01 UPC 3 16729 00101 4; b) 500-count bottle NDC 16729-001-16 UPC 3 16729 00116 8; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA",
      "product_quantity": "469,944 bottles",
      "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: a) R2000166, Exp. Date 4/30/2023, P2003528 Exp. Date 6/30/2023, P2005451 Exp. Date 8/31/2023, P2005438 Exp. Date 8/31/2023, P2005436 Exp. Date 8/31/2023, P2005437 Exp. Date 8/31/2023, P2005452 Exp. Date 8/31/2023, P2006055 Exp. Date 9/30/2023, P2101782 Exp. Date 2/28/2024, P2101783 Exp. Date 2/28/2024, P2101781 Exp. Date 2/29/2024, P2102171 Exp. Date 2/29/2024, P2101844 Exp. Date 3/31/2024, P2101846 Exp. Date 3/31/2024, P2101845 Exp. Date 3/31/2024; b) P2006510 Exp. Date 11/30/2023, P2100975 Exp. Date 1/31/2024, P2100625 Exp. Date 1/31/2024, P2101778 Exp. Date 2/29/2024, P2101779 Exp. Date 2/29/2024, P2103021 Exp. Date 4/30/2024, P2103020 Exp. Date 4/30/2024, R2100657 Exp. Date 5/31/2024, R2100656 Exp. Date 5/31/2024, R2100658 Exp. Date 5/31/2024, P2104735 Exp. Date 7/31/2024, P2104739 Exp. Date 7/31/2024, P2104737 Exp. Date 7/31/2024, P2104738 Exp. Date 7/31/2024, P2106260 Exp. Date 9/30/2024, P2107384 Exp. Date 9/30/2024, R2200045 Exp. Date 12/31/2024, R2200046 Exp. Date 12/31/2024, R2200054 Exp. Date 12/31/2024, R2200055 Exp. Date 12/31/2024, R2200057 Exp. Date 12/31/2024, R2200058 Exp. Date 12/31/2024, R2200053 Exp. Date 12/31/2024, R2200059 Exp. Date 12/31/2024, R2200056 Exp. Date 12/31/2024, P2201929 Exp. Date 2/28/2025, R2200663 Exp. Date 4/30/2025, P2203518 Exp. Date 5/31/2025, R2200897 Exp. Date 6/30/2025, R2200898 Exp. Date 6/30/2025, R2200899 Exp. Date 6/30/2025, P2205528 Exp. Date 8/31/2025",
      "more_code_info": ""
    }
  ]
}