{
  "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": "Verna",
      "state": "N/A",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA207016"
        ],
        "brand_name": [
          "TELMISARTAN"
        ],
        "generic_name": [
          "TELMISARTAN"
        ],
        "manufacturer_name": [
          "Micro Labs Limited"
        ],
        "product_ndc": [
          "42571-226",
          "42571-227",
          "42571-228"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TELMISARTAN"
        ],
        "rxcui": [
          "205304",
          "205305",
          "282755"
        ],
        "spl_id": [
          "f2aa8284-f86c-3425-e053-2995a90a6dc6"
        ],
        "spl_set_id": [
          "d7c9bd41-9558-46e1-ab03-82cdf85db3fe"
        ],
        "package_ndc": [
          "42571-226-30",
          "42571-226-90",
          "42571-226-05",
          "42571-226-10",
          "42571-226-32",
          "42571-226-11",
          "42571-226-41",
          "42571-227-30",
          "42571-227-90",
          "42571-227-05",
          "42571-227-10",
          "42571-227-32",
          "42571-227-11",
          "42571-227-41",
          "42571-228-30",
          "42571-228-90",
          "42571-228-05",
          "42571-228-10",
          "42571-228-32",
          "42571-228-11",
          "42571-228-41"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0342571228309",
          "0342571226305",
          "0342571227302"
        ],
        "nui": [
          "N0000000070",
          "N0000175561"
        ],
        "pharm_class_moa": [
          "Angiotensin 2 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Angiotensin 2 Receptor Blocker [EPC]"
        ],
        "unii": [
          "U5SYW473RQ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93965",
      "recalling_firm": "Micro Labs Limited",
      "address_1": "Plot# S - 155",
      "address_2": "& N1 Phase Iii & Phase Iv; Verna Ind Estate Road",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Puerto Rico, TN, RI",
      "recall_number": "D-0388-2024",
      "product_description": "Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873, NDC 42571-227-30.",
      "product_quantity": "118,080 bottles",
      "reason_for_recall": "Failed Stability Specifications: Out of specification for blend uniformity.",
      "recall_initiation_date": "20240209",
      "center_classification_date": "20240314",
      "termination_date": "20250624",
      "report_date": "20240320",
      "code_info": "Lot #s: SFBG024, SFBG025, Exp. 05/31/2024"
    }
  ]
}