{
  "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": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA216379"
        ],
        "brand_name": [
          "TIROFIBAN"
        ],
        "generic_name": [
          "TIROFIBAN"
        ],
        "manufacturer_name": [
          "Eugia US LLC"
        ],
        "product_ndc": [
          "55150-429",
          "55150-430"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "TIROFIBAN HYDROCHLORIDE"
        ],
        "rxcui": [
          "1737466",
          "1737471"
        ],
        "spl_id": [
          "1751523a-e22e-4faf-bdb1-c850afe2fd36"
        ],
        "spl_set_id": [
          "d554acff-22e9-4f28-b826-ee1b91daa2df"
        ],
        "package_ndc": [
          "55150-429-01",
          "55150-430-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355150430017",
          "0355150429011"
        ],
        "unii": [
          "6H925F8O5J"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96718",
      "recalling_firm": "Eugia US LLC",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA nationwide.",
      "recall_number": "D-0390-2025",
      "product_description": "Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-430-01",
      "product_quantity": "",
      "reason_for_recall": "Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.",
      "recall_initiation_date": "20250421",
      "center_classification_date": "20250425",
      "report_date": "20250507",
      "code_info": "Lot# : 3TF24001, Exp 3/31/2026",
      "more_code_info": ""
    }
  ]
}