{
  "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": "Berwyn",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA209080"
        ],
        "brand_name": [
          "TIGLUTIK"
        ],
        "generic_name": [
          "RILUZOLE"
        ],
        "manufacturer_name": [
          "EDW PHARMA, INC"
        ],
        "product_ndc": [
          "70726-0303"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "RILUZOLE"
        ],
        "rxcui": [
          "2058147",
          "2059266"
        ],
        "spl_id": [
          "4746e22f-8ca7-9149-e063-6294a90aea8d"
        ],
        "spl_set_id": [
          "75d68f19-4208-109e-e053-2991aa0ac857"
        ],
        "package_ndc": [
          "70726-0303-2",
          "70726-0303-1"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175740",
          "M0483511"
        ],
        "pharm_class_epc": [
          "Benzothiazole [EPC]"
        ],
        "pharm_class_cs": [
          "Benzothiazoles [CS]"
        ],
        "unii": [
          "7LJ087RS6F"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93278",
      "recalling_firm": "ITF PHARMA INC",
      "address_1": "850 Cassatt Rd",
      "address_2": "N/A",
      "postal_code": "19312-2701",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed to one distributor in TN who may have further distributed.",
      "recall_number": "D-0115-2024",
      "product_description": "Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for ITF Pharma, Inc., Berwyn, PA 19312 USA NDC:70726-0303-1 (carton) and 70726-0303-2 (bottle)",
      "product_quantity": "1,792 bottles",
      "reason_for_recall": "Failed Viscosity Specifications: Out-of-specification test results for viscosity",
      "recall_initiation_date": "20231020",
      "center_classification_date": "20231121",
      "termination_date": "20250128",
      "report_date": "20231129",
      "code_info": "LOT# 2231901, Exp. 11/30/2025; 2307901, Exp. 03/31/2026",
      "more_code_info": ""
    }
  ]
}