{
  "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": "Dawsonville",
      "state": "GA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA202289"
        ],
        "brand_name": [
          "LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "DirectRx"
        ],
        "product_ndc": [
          "72189-297"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROCHLOROTHIAZIDE",
          "LOSARTAN POTASSIUM"
        ],
        "rxcui": [
          "979468"
        ],
        "spl_id": [
          "2c294e17-bf06-cf97-e063-6394a90abafc"
        ],
        "spl_set_id": [
          "d2021060-94d7-3e1d-e053-2995a90a10ee"
        ],
        "package_ndc": [
          "72189-297-90"
        ],
        "original_packager_product_ndc": [
          "33342-050"
        ],
        "nui": [
          "N0000175359",
          "N0000175419",
          "M0471776"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_epc": [
          "Thiazide Diuretic [EPC]"
        ],
        "pharm_class_cs": [
          "Thiazides [CS]"
        ],
        "unii": [
          "0J48LPH2TH",
          "3ST302B24A"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90200",
      "recalling_firm": "Direct Rx",
      "address_1": "94 Worldwide Dr",
      "address_2": "",
      "postal_code": "30534-6828",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "FL",
      "recall_number": "D-0894-2022",
      "product_description": "Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540",
      "product_quantity": "6 bottles",
      "reason_for_recall": "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .",
      "recall_initiation_date": "20220511",
      "center_classification_date": "20220524",
      "termination_date": "20221202",
      "report_date": "20220601",
      "code_info": "Lots: 19NO2108 Exp. 1/31/25; 19NO2114 Exp. 1/31/25; 22NO2126 Exp. 1/31/25",
      "more_code_info": ""
    }
  ]
}