{
  "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": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA202544"
        ],
        "brand_name": [
          "TELMISARTAN AND HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "TELMISARTAN AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-840",
          "68462-841",
          "68462-842"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TELMISARTAN",
          "HYDROCHLOROTHIAZIDE"
        ],
        "rxcui": [
          "283316",
          "283317",
          "477130"
        ],
        "spl_id": [
          "697f1231-2483-4e0b-9e23-aeb576fa6171"
        ],
        "spl_set_id": [
          "1e55800d-f77c-4950-a6d7-2055f4c7ea17"
        ],
        "package_ndc": [
          "68462-840-13",
          "68462-841-13",
          "68462-842-13"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462842133",
          "0368462841136",
          "0368462840139"
        ],
        "nui": [
          "N0000000070",
          "N0000175561",
          "N0000175359",
          "N0000175419",
          "M0471776"
        ],
        "pharm_class_moa": [
          "Angiotensin 2 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Angiotensin 2 Receptor Blocker [EPC]",
          "Thiazide Diuretic [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_cs": [
          "Thiazides [CS]"
        ],
        "unii": [
          "U5SYW473RQ",
          "0J48LPH2TH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90541",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "nationwide",
      "recall_number": "D-1305-2022",
      "product_description": "Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430, NDC 68462-842-13.",
      "product_quantity": "72288 units",
      "reason_for_recall": "Defective Container: Recall of these batches has been initiated due to complaints of  difficult to open blister and tablet breaks while opening the blister .",
      "recall_initiation_date": "20220629",
      "center_classification_date": "20220805",
      "termination_date": "20240627",
      "report_date": "20220817",
      "code_info": "Lots 17210935 & 17210936., Exp Date  05/2023    Lot 17211206, Exp Date 06/2023       Lots 17211652, 17211655 & 17211658, Exp Date 08/2023",
      "more_code_info": ""
    }
  ]
}