{
  "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 III",
      "openfda": {
        "application_number": [
          "ANDA206127"
        ],
        "brand_name": [
          "EPTIFIBATIDE"
        ],
        "generic_name": [
          "EPTIFIBATIDE"
        ],
        "manufacturer_name": [
          "Eugia US LLC"
        ],
        "product_ndc": [
          "55150-218",
          "55150-219",
          "55150-220"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "EPTIFIBATIDE"
        ],
        "rxcui": [
          "200349",
          "1736470",
          "1736477"
        ],
        "spl_id": [
          "944b269c-d810-411d-9ed4-8edd9d0ac1b7"
        ],
        "spl_set_id": [
          "00ad7bbe-cadd-4647-b74b-adfc9f2b5e94"
        ],
        "package_ndc": [
          "55150-218-99",
          "55150-219-10",
          "55150-220-99"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355150220991",
          "0355150219100"
        ],
        "nui": [
          "N0000008832",
          "N0000175578"
        ],
        "pharm_class_pe": [
          "Decreased Platelet Aggregation [PE]"
        ],
        "pharm_class_epc": [
          "Platelet Aggregation Inhibitor [EPC]"
        ],
        "unii": [
          "NA8320J834"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94680",
      "recalling_firm": "Eugia US LLC",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "N/A",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA nationwide.",
      "recall_number": "D-0556-2024",
      "product_description": "Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ 08520, NDC 55150-219-10",
      "product_quantity": "15,500 single dose vials",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.",
      "recall_initiation_date": "20240522",
      "center_classification_date": "20240614",
      "report_date": "20240626",
      "code_info": "Lot #: 3EF22003, Exp 6/30/2025"
    }
  ]
}