{
  "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": [
          "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": "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-1457-2019",
      "product_description": "Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536   Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA   NDC 33342-045-10",
      "product_quantity": "47520 bottles (4,276,800 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": "BLI711A Nov 2019",
      "more_code_info": ""
    }
  ]
}