{
  "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": "Ongoing",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA079135"
        ],
        "brand_name": [
          "TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE"
        ],
        "generic_name": [
          "TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-294",
          "68462-329",
          "68462-295",
          "68462-296"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TRANDOLAPRIL",
          "VERAPAMIL HYDROCHLORIDE"
        ],
        "rxcui": [
          "897781",
          "897783",
          "897844",
          "897853"
        ],
        "spl_id": [
          "770b4914-a475-4841-83f8-79261f115eff"
        ],
        "spl_set_id": [
          "39bad727-af4c-4d20-933b-7f287e88099a"
        ],
        "package_ndc": [
          "68462-329-01",
          "68462-329-10",
          "68462-295-01",
          "68462-295-10",
          "68462-295-90",
          "68462-296-01",
          "68462-296-10",
          "68462-296-90",
          "68462-294-01",
          "68462-294-10",
          "68462-294-90"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462294017",
          "0368462329016"
        ],
        "nui": [
          "N0000175562",
          "N0000000181"
        ],
        "pharm_class_epc": [
          "Angiotensin Converting Enzyme Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Angiotensin-converting Enzyme Inhibitors [MoA]"
        ],
        "unii": [
          "V3888OEY5R",
          "1T0N3G9CRC"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92859",
      "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 U.S.",
      "recall_number": "D-1095-2023",
      "product_description": "Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01",
      "product_quantity": "1,200 bottles",
      "reason_for_recall": "Subpotent: Out of Specification for Assay Test at the 3-month time point.",
      "recall_initiation_date": "20230814",
      "center_classification_date": "20230822",
      "report_date": "20230830",
      "code_info": "Batch # 19224744"
    }
  ]
}