{
  "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": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076286"
        ],
        "brand_name": [
          "TIZANIDINE"
        ],
        "generic_name": [
          "TIZANIDINE"
        ],
        "manufacturer_name": [
          "American Health Packaging"
        ],
        "product_ndc": [
          "68084-645",
          "68084-775"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TIZANIDINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "313412",
          "313413"
        ],
        "spl_id": [
          "35bfea02-ba73-d8c2-e063-6394a90a5c9f"
        ],
        "spl_set_id": [
          "3670f9e3-988d-48e6-9df0-d403d699e08a"
        ],
        "package_ndc": [
          "68084-645-11",
          "68084-645-01",
          "68084-645-65",
          "68084-775-95",
          "68084-775-25"
        ],
        "original_packager_product_ndc": [
          "55111-180",
          "55111-179"
        ],
        "unii": [
          "B53E3NMY5C"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92607",
      "recalling_firm": "Amerisource Health Services LLC",
      "address_1": "2550 John Glenn Ave Ste A",
      "address_2": "N/A",
      "postal_code": "43217-1188",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0892-2023",
      "product_description": "Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-645-01 (carton), barcode (01) 003 68084 645 11 2.",
      "product_quantity": "4,971 cartons",
      "reason_for_recall": "Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.",
      "recall_initiation_date": "20230623",
      "center_classification_date": "20230630",
      "termination_date": "20240906",
      "report_date": "20230712",
      "code_info": "Lot 1004835, Exp 7/31/2023"
    }
  ]
}