{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bridgewater",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "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"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355111180104",
          "0355111179108"
        ],
        "unii": [
          "B53E3NMY5C"
        ]
      },
      "product_type": "Drugs",
      "event_id": "64733",
      "recalling_firm": "Dr. Reddy'S Laboratories",
      "address_1": "200 Somerset Corporate Blvd FL 7",
      "address_2": "Blvd 11 7th Floor",
      "postal_code": "08807-2862",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico.",
      "recall_number": "D-238-2013",
      "product_description": "Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepally - 500 090 India; NDC 55111-180-15.",
      "product_quantity": "117,546 bottles",
      "reason_for_recall": "Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.",
      "recall_initiation_date": "20130319",
      "center_classification_date": "20130401",
      "termination_date": "20140206",
      "report_date": "20130410",
      "code_info": "Lot #: C208625, C208984, C209113, C209369, Exp 09/15; and C209680, Exp 10/15."
    }
  ]
}