{
  "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": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA215995"
        ],
        "brand_name": [
          "BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "GLENMARK PHARMACEUTICALS INC., USA"
        ],
        "product_ndc": [
          "68462-878",
          "68462-879",
          "68462-880"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BISOPROLOL FUMARATE",
          "HYDROCHLOROTHIAZIDE"
        ],
        "rxcui": [
          "854908",
          "854916",
          "854919"
        ],
        "spl_id": [
          "6154a348-821d-46cc-a830-ac5684f9525a"
        ],
        "spl_set_id": [
          "ab73a6d8-2e33-4fdc-a896-6c68ab772da6"
        ],
        "package_ndc": [
          "68462-878-30",
          "68462-878-01",
          "68462-878-05",
          "68462-879-30",
          "68462-879-01",
          "68462-879-05",
          "68462-880-30",
          "68462-880-01",
          "68462-880-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462880302",
          "0368462879306",
          "0368462878309"
        ],
        "nui": [
          "N0000175359",
          "N0000175419",
          "M0471776"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_epc": [
          "Thiazide Diuretic [EPC]"
        ],
        "pharm_class_cs": [
          "Thiazides [CS]"
        ],
        "unii": [
          "UR59KN573L",
          "0J48LPH2TH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93252",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0085-2024",
      "product_description": "Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01",
      "product_quantity": "480 100-count bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications",
      "recall_initiation_date": "20231020",
      "center_classification_date": "20231102",
      "termination_date": "20240816",
      "report_date": "20231108",
      "code_info": "Lot# 17212352, Exp 11/31/2023"
    }
  ]
}