{
  "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": "2026-03-18",
    "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": [
          "HYDROCHLOROTHIAZIDE",
          "LOSARTAN POTASSIUM"
        ],
        "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": "83151",
      "recalling_firm": "Macleods Pharma Usa Inc",
      "address_1": "666 Plainsboro Rd Bldg 200 Ste 230",
      "address_2": "",
      "postal_code": "08536-0009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1460-2019",
      "product_description": "Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP  Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536   Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA     NDC 33342-051-10",
      "product_quantity": "29106 bottles (2,619,540 tablets)",
      "reason_for_recall": "CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.",
      "recall_initiation_date": "20190620",
      "center_classification_date": "20190709",
      "termination_date": "20211026",
      "report_date": "20190717",
      "code_info": "BLL801A Dec-19  BLL802A Dec-19  BLL803A Dec-19",
      "more_code_info": ""
    }
  ]
}