{
  "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": "Baltimore",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078245"
        ],
        "brand_name": [
          "LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-215",
          "68180-216",
          "68180-217"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROCHLOROTHIAZIDE",
          "LOSARTAN POTASSIUM"
        ],
        "rxcui": [
          "979464",
          "979468",
          "979471"
        ],
        "spl_id": [
          "6b0e9bc3-30a9-47ce-8cbe-c51404d51ae6"
        ],
        "spl_set_id": [
          "ee1eaaf6-050b-48af-942b-5e3451edc164"
        ],
        "package_ndc": [
          "68180-215-09",
          "68180-215-03",
          "68180-215-01",
          "68180-215-06",
          "68180-216-06",
          "68180-216-09",
          "68180-216-01",
          "68180-216-03",
          "68180-217-06",
          "68180-217-09",
          "68180-217-01",
          "68180-217-03"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368180215066",
          "0368180217060"
        ],
        "nui": [
          "N0000175359",
          "N0000175419",
          "M0471776"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_epc": [
          "Thiazide Diuretic [EPC]"
        ],
        "pharm_class_cs": [
          "Thiazides [CS]"
        ],
        "unii": [
          "3ST302B24A",
          "0J48LPH2TH"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89916",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "Harborplace Tower",
      "address_2": "111 S Calvert St Fl 21st",
      "postal_code": "21202-6174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed nationwide",
      "recall_number": "D-0843-2022",
      "product_description": "Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg  a) 30-count bottles (NDC# 68180-216-06)  b) 90-count bottles (NDC# 68180-216-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA",
      "product_quantity": "2,361,924 bottles",
      "reason_for_recall": "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits",
      "recall_initiation_date": "20220331",
      "center_classification_date": "20220503",
      "termination_date": "20230522",
      "report_date": "20220511",
      "code_info": "Lot #  H001878 6/30/2022 68180-216-06  H002178 7/31/2022 68180-216-06  H002626 9/30/2022 68180-216-06  H102149 9/30/2023 68180-216-06  H001600 5/31/2022 68180-216-09  H001601 5/1/2022         68180-216-09  H001625 5/31/2022 68180-216-09  H001626 5/31/2022 68180-216-09  H001794 6/30/2022 68180-216-09  H001795 6/30/2022 68180-216-09  H001796 6/30/2022 68180-216-09  H001797 6/30/2022 68180-216-09  H001879 6/30/2022 68180-216-09  H001880 6/30/2022 68180-216-09  H001881 6/30/2022 68180-216-09  H001942 6/30/2022 68180-216-09  H001943 6/30/2022 68180-216-09  H001944 6/30/2022 68180-216-09  H001945 6/30/2022 68180-216-09  H001946 6/30/2022 68180-216-09  H002179 7/31/2022 68180-216-09  H002180 7/31/2022 68180-216-09  H002181 8/31/2022 68180-216-09  H002182 8/31/2022 68180-216-09  H002183 8/31/2022 68180-216-09  H002237 8/31/2022 68180-216-09  H002238 8/31/2022 68180-216-09  H002239 8/31/2022 68180-216-09  H002240 8/31/2022 68180-216-09  H002241 8/31/2022 68180-216-09  H002627 9/30/2022 68180-216-09  H002628 9/30/2022 68180-216-09  H002629 9/30/2022 68180-216-09  H002630 9/30/2022 68180-216-09  H002631 9/30/2022 68180-216-09  H002979 11/30/2022 68180-216-09  H002980 11/30/2022 68180-216-09  H002981 11/30/2022 68180-216-09  H002982 11/30/2022 68180-216-09  H002983 11/30/2022 68180-216-09  H100112 12/31/2022 68180-216-09  H100113 12/31/2022 68180-216-09  H100114 12/31/2022 68180-216-09  H100115 12/31/2022 68180-216-09  H100116 12/31/2022 68180-216-09  H100156 12/31/2022 68180-216-09  H100157 12/31/2022 68180-216-09  H100622 2/28/2023 68180-216-09  H100623 2/28/2023 68180-216-09  H100624 2/28/2023 68180-216-09  H100625 2/28/2023 68180-216-09  H100626 2/28/2023 68180-216-09  H100627 2/28/2023 68180-216-09  H100628 2/28/2023 68180-216-09  H100629 2/28/2023 68180-216-09  H100939 4/30/2023 68180-216-09  H100940 4/30/2023 68180-216-09  H100941 4/30/2023 68180-216-09  H100942 4/30/2023 68180-216-09  H100943 4/30/2023 68180-216-09  H101094 5/31/2023 68180-216-09  H101095 5/31/2023 68180-216-09  H101096 5/31/2023 68180-216-09  H101097 5/31/2023 68180-216-09  H101098 5/31/2023 68180-216-09  H101151 5/31/2023 68180-216-09  H101152 5/31/2023 68180-216-09  H101290 5/31/2023 68180-216-09  H101291 5/31/2023 68180-216-09  H101292 5/31/2023 68180-216-09  H101293 5/31/2023 68180-216-09  H101323 5/31/2023 68180-216-09  H101324 5/31/2023 68180-216-09  H101823 7/31/2023 68180-216-09  H101824 7/31/2023 68180-216-09  H101825 7/31/2023 68180-216-09  H101853 8/31/2023 68180-216-09  H101854 8/31/2023 68180-216-09  H101855 8/31/2023 68180-216-09  H101856 8/31/2023 68180-216-09  H102127 9/30/2023 68180-216-09  H102128 9/30/2023 68180-216-09  H102129 9/30/2023 68180-216-09  H102130 9/30/2023 68180-216-09  H102150 9/30/2023 68180-216-09  H102151 9/30/2023 68180-216-09  H102152 9/30/2023 68180-216-09  H102153 9/30/2023 68180-216-09  H102154 9/30/2023 68180-216-09  H102155 9/30/2023 68180-216-09  H102201 9/30/2023 68180-216-09  H102223 9/30/2023 68180-216-09  H102268 9/30/2023 68180-216-09  H102269 9/30/2023 68180-216-09  H102270 9/30/2023 68180-216-09  H102271 9/30/2023 68180-216-09"
    }
  ]
}