{
  "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-1459-2019",
      "product_description": "Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 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 33342-050-10",
      "product_quantity": "142626 bottles (12,836,340 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": "BLK719A Sep-19  BLK720A Sep-19  BLK721A Sep-19  BLK722A Sep-19  BLK723A Sep-19  BLK724A Sep-19  BLK725A Oct-19  BLK726A Oct-19  BLK804A Jan-20  BLK806A Jan-20  BLK825A Oct-21  BLK826A Oct-21",
      "more_code_info": ""
    }
  ]
}