{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA209864"
        ],
        "brand_name": [
          "EPTIFIBATIDE"
        ],
        "generic_name": [
          "EPTIFIBATIDE"
        ],
        "manufacturer_name": [
          "Slate Run Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "70436-026",
          "70436-027",
          "70436-162",
          "70436-163"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "EPTIFIBATIDE"
        ],
        "rxcui": [
          "200349",
          "1736470"
        ],
        "spl_id": [
          "4a613f2d-85b3-d45c-e063-6294a90adb93",
          "4a614df8-4e1d-d610-e063-6294a90a7d7c"
        ],
        "spl_set_id": [
          "da421d88-6c00-428a-82a6-b3b4f7a68b85",
          "2ab98ecd-c578-4032-a3d5-ae14d58d86a7"
        ],
        "package_ndc": [
          "70436-026-80",
          "70436-027-80",
          "70436-162-80",
          "70436-163-80"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0370436027804",
          "0370436163809"
        ],
        "nui": [
          "N0000008832",
          "N0000175578"
        ],
        "pharm_class_pe": [
          "Decreased Platelet Aggregation [PE]"
        ],
        "pharm_class_epc": [
          "Platelet Aggregation Inhibitor [EPC]"
        ],
        "unii": [
          "NA8320J834"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98416",
      "recalling_firm": "Slate Run Pharmaceuticals",
      "address_1": "277 W Nationwide Blvd Ste 260",
      "address_2": "N/A",
      "postal_code": "43215-0169",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the USA.",
      "recall_number": "D-0343-2026",
      "product_description": "Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215.  NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80",
      "product_quantity": "N/A",
      "reason_for_recall": "Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.",
      "recall_initiation_date": "20260212",
      "center_classification_date": "20260223",
      "report_date": "20260304",
      "code_info": "All lots within expiry"
    }
  ]
}