{
  "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": "2026-07-08",
    "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-0972-2022",
      "product_description": "Losartan Potassium Tablets, USP 25 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 64380-933-05  1000 film coated tablets NDC 64380-933-08",
      "product_quantity": "200407 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 64380-933-05  Lot 7901007A, Exp Date Jun-22; Lot 7901144A, 7901178A & 7901179A, Exp Date Sep-22; Lots 7901246A & 7901247A, Exp Date Oct-22; Lot 7901343A, Exp Date Dec-22.  NDC 64380-933-08   Lot 7901006A, Exp Date Jun-22; Lot 7901145A & 7901180A, Exp Date Sep-22; Lot 7901181A, Exp Date Oct-22."
    }
  ]
}