{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Baltimore",
      "state": "MD",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA077912"
        ],
        "brand_name": [
          "LISINOPRIL AND HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "LISINOPRIL AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-518",
          "68180-519",
          "68180-520"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROCHLOROTHIAZIDE",
          "LISINOPRIL"
        ],
        "rxcui": [
          "197885",
          "197886",
          "197887"
        ],
        "spl_id": [
          "4035482a-7e09-464f-ae01-a8a75fc3c4c1"
        ],
        "spl_set_id": [
          "515f735c-5dba-43d9-8a58-97a319cafd56"
        ],
        "package_ndc": [
          "68180-518-02",
          "68180-518-01",
          "68180-518-30",
          "68180-519-30",
          "68180-519-01",
          "68180-519-02",
          "68180-520-02",
          "68180-520-30",
          "68180-520-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368180519010",
          "0368180518013",
          "0368180520016"
        ],
        "nui": [
          "N0000175359",
          "N0000175419",
          "M0471776"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_epc": [
          "Thiazide Diuretic [EPC]"
        ],
        "pharm_class_cs": [
          "Thiazides [CS]"
        ],
        "unii": [
          "E7199S1YWR",
          "0J48LPH2TH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "73848",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "111 S Calvert St Fl 21ST",
      "address_2": "",
      "postal_code": "21202-6174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-1052-2016",
      "product_description": "Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30",
      "product_quantity": "59,520 Bottles",
      "reason_for_recall": "CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.",
      "recall_initiation_date": "20160404",
      "center_classification_date": "20160624",
      "termination_date": "20170601",
      "report_date": "20160706",
      "code_info": "Lot #: a) H303459, b) H303460, Exp 09/2016",
      "more_code_info": ""
    }
  ]
}