{
  "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": "East Brunswick",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090382"
        ],
        "brand_name": [
          "LOSARTAN POTASSIUM"
        ],
        "generic_name": [
          "LOSARTAN POTASSIUM"
        ],
        "manufacturer_name": [
          "Strides Pharma Science Limited"
        ],
        "product_ndc": [
          "64380-933",
          "64380-934",
          "64380-935"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LOSARTAN POTASSIUM"
        ],
        "rxcui": [
          "979480",
          "979485",
          "979492"
        ],
        "spl_id": [
          "de8fc110-fa21-4904-8309-fd3c28dfff44"
        ],
        "spl_set_id": [
          "a8817f22-8478-49b9-8354-ab27ca222c6b"
        ],
        "package_ndc": [
          "64380-933-04",
          "64380-933-05",
          "64380-933-08",
          "64380-934-04",
          "64380-934-05",
          "64380-934-08",
          "64380-935-04",
          "64380-935-05",
          "64380-935-08"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0364380933052",
          "0364380935056",
          "0364380935087",
          "0364380935049",
          "0364380934042",
          "0364380933045",
          "0364380934080",
          "0364380933083",
          "0364380934059"
        ],
        "unii": [
          "3ST302B24A"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90229",
      "recalling_firm": "Strides Pharma Inc.",
      "address_1": "2 Tower Center Blvd Ste 1102",
      "address_2": "N/A",
      "postal_code": "08816-1100",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0973-2022",
      "product_description": "Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816.    90 film coated tablets NDC 64380-934-05  1000 film coated tablets NDC 64380-934-08",
      "product_quantity": "381456 bottles",
      "reason_for_recall": "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits",
      "recall_initiation_date": "20220518",
      "center_classification_date": "20220528",
      "termination_date": "20231020",
      "report_date": "20220608",
      "code_info": "NDC 64380-934-05  Lot 7901146A, 7901147A, 7901148A & 7901149A, Exp Date Sep-22; Lot 7901279A, 7901280A, 7901281A, 7901282A, 7901283A & 7901284A, Exp Date Nov-22; Lot 7901359A, 7901360A & 7901361A, Exp Date Dec-22; Lot 7901362A, 7901406A, 7901407A, 7901408A & 7901409A, Exp Date Jan-23.   64380-934-08  Lot 7901008A & 7901009A, Exp Date Jun-22; Lot 7901150A & 7901151A, Exp Date Sep-22; Lot 7901285B, 7901286B, 7901287A, 7901288A, 7901289A, 7901290A, 7901291A, 7901292A, 7901293A & 7901294A, Exp Date Nov-22."
    }
  ]
}