{
  "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": [
          "ANDA202230"
        ],
        "brand_name": [
          "LOSARTAN POTASSIUM"
        ],
        "generic_name": [
          "LOSARTAN POTASSIUM"
        ],
        "manufacturer_name": [
          "Macleods Pharmaceuticals Limited"
        ],
        "product_ndc": [
          "33342-044",
          "33342-045",
          "33342-046"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LOSARTAN POTASSIUM"
        ],
        "rxcui": [
          "979480",
          "979485",
          "979492"
        ],
        "spl_id": [
          "81824d1f-61f4-457c-8723-cd43d5429029"
        ],
        "spl_set_id": [
          "85d69d02-c5ef-467e-94aa-903100218795"
        ],
        "package_ndc": [
          "33342-044-10",
          "33342-044-12",
          "33342-044-07",
          "33342-044-44",
          "33342-045-10",
          "33342-045-12",
          "33342-045-07",
          "33342-045-44",
          "33342-046-10",
          "33342-046-12",
          "33342-046-07",
          "33342-046-44"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3ST302B24A"
        ]
      },
      "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-0834-2022",
      "product_description": "Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536",
      "product_quantity": "3288/30 count bottles; 23,904/90 count bottles; 3364/1000 count bottles = 5,614,000 tablets",
      "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 #  BLI2107B, exp. date 06/2023  BLI2101A, exp. date 12/2022  BLI2103A, exp. date 12/2022  BLI2105A, exp. date 05/2023"
    }
  ]
}