{
  "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": "Dublin",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077857"
        ],
        "brand_name": [
          "ENOXAPARIN SODIUM"
        ],
        "generic_name": [
          "ENOXAPARIN SODIUM"
        ],
        "manufacturer_name": [
          "Cardinal Health 107, LLC",
          "Sandoz Inc"
        ],
        "product_ndc": [
          "55154-3540",
          "55154-3541",
          "55154-3542",
          "55154-3543",
          "55154-3544",
          "0781-3238",
          "0781-3246",
          "0781-3256",
          "0781-3262",
          "0781-3268",
          "0781-3298",
          "0781-3299"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "ENOXAPARIN SODIUM"
        ],
        "rxcui": [
          "854228",
          "854235",
          "854238",
          "854241",
          "854248",
          "854245",
          "854252"
        ],
        "spl_id": [
          "5894db55-5339-46b2-9683-4a1d35d4adf4",
          "82c50153-58b8-4c35-8fc2-1d9b3d3ac7de"
        ],
        "spl_set_id": [
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          "38f60bd8-b518-4098-a808-b8f5a3ae6a3a"
        ],
        "package_ndc": [
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          "55154-3541-5",
          "55154-3542-5",
          "55154-3543-5",
          "55154-3544-5",
          "0781-3238-01",
          "0781-3238-63",
          "0781-3246-02",
          "0781-3246-64",
          "0781-3256-03",
          "0781-3256-66",
          "0781-3262-04",
          "0781-3262-68",
          "0781-3268-05",
          "0781-3268-69",
          "0781-3298-04",
          "0781-3298-68",
          "0781-3299-05",
          "0781-3299-69"
        ],
        "original_packager_product_ndc": [
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          "0781-3246",
          "0781-3256",
          "0781-3262",
          "0781-3268"
        ],
        "upc": [
          "0055154354059",
          "0055154354455",
          "0055154354257",
          "0055154354158"
        ],
        "unii": [
          "8NZ41MIK1O"
        ],
        "is_original_packager": [
          true
        ]
      },
      "product_type": "Drugs",
      "event_id": "97380",
      "recalling_firm": "Cardinal Health Inc.",
      "address_1": "7000 Cardinal Pl",
      "address_2": "",
      "postal_code": "43017-1091",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "KS",
      "recall_number": "D-0597-2025",
      "product_description": "Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 prefilled syringes, Rx Only, Dist. by: Sandoz Inc., Princeton, NJ 08540, Outer package - NDC 55154-3543-5, Inner label - NDC 0781-3238-01",
      "product_quantity": "10 bags",
      "reason_for_recall": "Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL",
      "recall_initiation_date": "20250805",
      "center_classification_date": "20250822",
      "report_date": "20250903",
      "code_info": "Outer package - NDC 55154-3543-5, Lot SAD08033AA   Inner label - NDC 0781-3238-01, Lot SAF13211A",
      "more_code_info": ""
    }
  ]
}