{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA202289"
        ],
        "brand_name": [
          "LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE"
        ],
        "generic_name": [
          "LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE"
        ],
        "manufacturer_name": [
          "Macleods Pharmaceuticals Limited"
        ],
        "product_ndc": [
          "33342-050",
          "33342-051",
          "33342-052"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LOSARTAN POTASSIUM",
          "HYDROCHLOROTHIAZIDE"
        ],
        "rxcui": [
          "979464",
          "979468",
          "979471"
        ],
        "spl_id": [
          "cf31d31e-9355-47da-9c2b-8e4b84ac8159"
        ],
        "spl_set_id": [
          "a04b5622-2c49-4d61-92b1-5dc523af7a24"
        ],
        "package_ndc": [
          "33342-050-07",
          "33342-050-10",
          "33342-050-44",
          "33342-050-12",
          "33342-051-07",
          "33342-051-10",
          "33342-051-44",
          "33342-051-12",
          "33342-052-07",
          "33342-052-10",
          "33342-052-44",
          "33342-052-12"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0333342051448",
          "0333342050106",
          "0333342052100",
          "0333342051103",
          "0333342052445",
          "0333342051073",
          "0333342052070"
        ],
        "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": "94592",
      "recalling_firm": "MACLEODS PHARMA USA, INC",
      "address_1": "103 College Rd E Fl 2",
      "address_2": "N/A",
      "postal_code": "08540-6611",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0498-2024",
      "product_description": "Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44",
      "product_quantity": "1,048 bottles",
      "reason_for_recall": "Presence of foreign substance: plastic-like substance.",
      "recall_initiation_date": "20240507",
      "center_classification_date": "20240515",
      "report_date": "20240522",
      "code_info": "Lot #: BLK2304A, Exp. 07/31/2025"
    }
  ]
}