{
  "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": "Ongoing",
      "city": "Anaheim",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076286"
        ],
        "brand_name": [
          "TIZANIDINE"
        ],
        "generic_name": [
          "TIZANIDINE"
        ],
        "manufacturer_name": [
          "Preferred Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68788-7781"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "TIZANIDINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "313413"
        ],
        "spl_id": [
          "c2ed0d31-f724-4410-85b9-eb03eb7ab9bc"
        ],
        "spl_set_id": [
          "32c3be66-5398-425c-ac65-e57ba819bb43"
        ],
        "package_ndc": [
          "68788-7781-2",
          "68788-7781-3",
          "68788-7781-6",
          "68788-7781-9",
          "68788-7781-1",
          "68788-7781-8"
        ],
        "original_packager_product_ndc": [
          "55111-180"
        ],
        "unii": [
          "B53E3NMY5C"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92625",
      "recalling_firm": "Preferred Pharmaceuticals, Inc.",
      "address_1": "1250 N Lakeview Ave Ste O",
      "address_2": "N/A",
      "postal_code": "92807-1801",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0894-2023",
      "product_description": "Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68788-7781-9), e) 120-count bottles (NDC: 68788-7781-8), Rx only, Mfg: Dr. Reddy's Laboratories Limited.",
      "product_quantity": "541 Bottles",
      "reason_for_recall": "Failed Stability Specifications",
      "recall_initiation_date": "20230626",
      "center_classification_date": "20230705",
      "report_date": "20230712",
      "code_info": "Lot#: a) H1621S, Exp: 12/31/2023; b) H2321C, Exp: 12/31/2023; c) H0421B, Exp: 12/31/2023; d) H1721E, H1921T, H3121M, Exp: 12/31/2023, e) H2021G, Exp: 12/31/2023"
    }
  ]
}