{
  "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": "Plainsboro",
      "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": "90037",
      "recalling_firm": "Macleods Pharma Usa Inc",
      "address_1": "666 Plainsboro Rd Bldg 200 Ste 230",
      "address_2": "N/A",
      "postal_code": "08536-0009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed nationwide.",
      "recall_number": "D-0835-2022",
      "product_description": "Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-count bottles (NDC # 33342-050-10)  c) 1000-count bottles (NDC # 33342-050-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536",
      "product_quantity": "N/A",
      "reason_for_recall": "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits",
      "recall_initiation_date": "20220415",
      "center_classification_date": "20220503",
      "termination_date": "20231013",
      "report_date": "20220511",
      "code_info": "Lot #   BLK2107B, exp. date 05/2023  BLK2101A, exp. date 01/2025  BLK2102A, exp. date 02/2025  BLK2103B, exp. date 02/2023  BLK2103C, exp. date 02/2023  BLK2104A, exp. date 05/2023"
    }
  ]
}