{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076286"
        ],
        "brand_name": [
          "TIZANIDINE"
        ],
        "generic_name": [
          "TIZANIDINE"
        ],
        "manufacturer_name": [
          "Dr. Reddy's Laboratories Limited"
        ],
        "product_ndc": [
          "55111-179",
          "55111-180"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TIZANIDINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "313412",
          "313413"
        ],
        "spl_id": [
          "386ec98d-4a47-b025-b050-7e4ebce382c6"
        ],
        "spl_set_id": [
          "a42f3479-f2c2-8214-d547-c5cae9bfed1e"
        ],
        "package_ndc": [
          "55111-179-30",
          "55111-179-15",
          "55111-179-03",
          "55111-179-10",
          "55111-180-30",
          "55111-180-15",
          "55111-180-03",
          "55111-180-10",
          "3551117915"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355111180104",
          "0355111179108"
        ],
        "unii": [
          "B53E3NMY5C"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80953",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-1191-2018",
      "product_description": "Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55111-179-15, UPC 35511179153",
      "product_quantity": "8376 units",
      "reason_for_recall": "Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .",
      "recall_initiation_date": "20180904",
      "center_classification_date": "20180917",
      "termination_date": "20220301",
      "report_date": "20180926",
      "code_info": "Lot #: T800304, Exp. 03/2021"
    }
  ]
}