{
  "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-0842-2022",
      "product_description": "Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg  a) 30-count bottles (NDC# 68180-217-06)  b) 90-count bottles (NDC# 68180-217-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA",
      "product_quantity": "303,696 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 #  H001156 4/30/2022 68180-217-06  H001627 5/31/2022 68180-217-06  H001947 6/30/2022 68180-217-06  H002242 8/31/2022 68180-217-06  H101826 7/31/2023 68180-217-06  H001155 4/30/2022 68180-217-09  H001355 5/31/2022 68180-217-09  H001356 5/31/2022 68180-217-09  H001357 5/31/2022 68180-217-09  H001358 5/31/2022 68180-217-09  H001359 5/31/2022 68180-217-09  H001371 5/31/2022 68180-217-09  H001372 5/31/2022 68180-217-09  H001373 5/31/2022 68180-217-09  H001374 5/31/2022 68180-217-09  H001375 5/31/2022 68180-217-09  H001628 5/31/2022 68180-217-09  H001629 5/31/2022 68180-217-09  H001630 6/30/2022 68180-217-09  H001645 6/30/2022 68180-217-09  H001646 6/30/2022 68180-217-09  H001647 6/30/2022 68180-217-09  H001798 6/30/2022 68180-217-09  H001799 6/30/2022 68180-217-09  H001882 6/30/2022 68180-217-09  H001883 6/30/2022 68180-217-09  H001948 6/30/2022 68180-217-09  H001949 6/30/2022 68180-217-09  H001985 6/30/2022 68180-217-09  H001986 6/30/2022 68180-217-09  H001987 7/31/2022 68180-217-09  H001988 7/31/2022 68180-217-09  H001989 7/31/2022 68180-217-09  H001990 7/31/2022 68180-217-09  H002243 8/31/2022 68180-217-09  H002244 8/31/2022 68180-217-09  H002245 8/31/2022 68180-217-09  H002315 8/31/2022 68180-217-09  H002316 8/31/2022 68180-217-09  H002317 8/31/2022 68180-217-09  H002318 8/31/2022 68180-217-09  H002319 8/31/2022 68180-217-09  H002320 8/31/2022 68180-217-09  H002321 8/31/2022 68180-217-09  H002322 8/31/2022 68180-217-09  H002323 8/31/2022 68180-217-09  H002324 8/31/2022 68180-217-09  H002632 9/30/2022 68180-217-09  H002633 9/30/2022 68180-217-09  H002634 9/30/2022 68180-217-09  H002635 9/30/2022 68180-217-09  H002636 9/30/2022 68180-217-09  H002765 9/30/2022 68180-217-09  H002766 9/30/2022 68180-217-09  H002767 9/30/2022 68180-217-09  H002768 9/30/2022 68180-217-09  H002769 9/30/2022 68180-217-09  H002770 9/30/2022 68180-217-09  H003194 11/30/2022 68180-217-09  H003195 11/30/2022 68180-217-09  H100009 12/31/2022 68180-217-09  H100010 12/31/2022 68180-217-09  H100021 12/31/2022 68180-217-09  H100022 12/31/2022 68180-217-09  H100023 12/31/2022 68180-217-09  H100029 12/31/2022 68180-217-09  H100030 12/31/2022 68180-217-09  H100342 1/31/2023 68180-217-09  H100343 1/31/2023 68180-217-09  H100344 1/31/2023 68180-217-09  H100345 1/31/2023 68180-217-09  H100346 1/31/2023 68180-217-09  H100374 1/31/2023 68180-217-09  H100375 1/31/2023 68180-217-09  H100376 1/31/2023 68180-217-09  H100377 1/31/2023 68180-217-09  H100378 1/31/2023 68180-217-09  H100452 1/31/2023 68180-217-09  H100453 1/31/2023 68180-217-09  H100454 2/28/2023 68180-217-09  H100458 2/28/2023 68180-217-09  H100459 2/28/2023 68180-217-09  H100652 2/28/2023 68180-217-09  H100653 2/28/2023 68180-217-09  H100654 2/28/2023 68180-217-09  H100655 2/28/2023 68180-217-09  H100656 2/28/2023 68180-217-09  H100687 2/28/2023 68180-217-09  H100688 2/28/2023 68180-217-09  H100689 2/28/2023 68180-217-09  H100703 2/28/2023 68180-217-09  H100704 2/28/2023 68180-217-09  H100891 3/31/2023 68180-217-09  H100892 3/31/2023 68180-217-09  H100902 3/31/2023 68180-217-09  H100903 3/31/2023 68180-217-09  H100904 3/31/2023 68180-217-09  H100905 3/31/2023 68180-217-09  H100936 3/31/2023 68180-217-09  H100937 3/31/2023 68180-217-09  H100938 3/31/2023 68180-217-09  H101153 5/31/2023 68180-217-09  H101154 5/31/2023 68180-217-09  H101155 5/31/2023 68180-217-09  H101156 5/31/2023 68180-217-09  H101157 5/31/2023 68180-217-09  H101158 5/31/2023 68180-217-09  H101159 5/31/2023 68180-217-09  H101294 5/31/2023 68180-217-09  H101295 5/31/2023 68180-217-09  H101296 5/31/2023 68180-217-09  H101297 5/31/2023 68180-217-09  H101325 5/31/2023 68180-217-09  H101326 6/30/2023 68180-217-09  H101327 6/30/2023 68180-217-09  H101328 6/30/2023 68180-217-09  H101349 6/30/2023 68180-217-09  H101350 6/30/2023 68180-217-09  H101351 6/30/2023 68180-217-09  H101352 6/30/2023 68180-217-09  H101482 6/30/2023 68180-217-09  H101483 6/30/2023 68180-217-09  H101606 7/31/2023 68180-217-09  H101618 7/31/2023 68180-217-09  H101619 7/31/2023 68180-217-09  H101620 7/31/2023 68180-217-09  H101621 7/31/2023 68180-217-09  H101827 7/31/2023 68180-217-09  H101828 7/31/2023 68180-217-09  H101829 7/31/2023 68180-217-09  H101857 7/31/2023 68180-217-09  H101858 7/31/2023 68180-217-09  H101911 7/31/2023 68180-217-09  H101912 7/31/2023 68180-217-09  H101913 7/31/2023 68180-217-09  H102455 10/31/2023 68180-217-09  H102456 10/31/2023 68180-217-09  H102457 10/31/2023 68180-217-09  H102458 10/31/2023 68180-217-09  H102485 10/31/2023 68180-217-09  H102489 10/31/2023 68180-217-09  H102490 10/31/2023 68180-217-09  H102491 10/31/2023 68180-217-09"
    }
  ]
}