{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bridgewater",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA020164"
        ],
        "brand_name": [
          "ENOXAPARIN SODIUM"
        ],
        "generic_name": [
          "ENOXAPARIN SODIUM"
        ],
        "manufacturer_name": [
          "Sanofi-Aventis U.S. LLC"
        ],
        "product_ndc": [
          "0955-1004",
          "0955-1003",
          "0955-1006",
          "0955-1008",
          "0955-1010",
          "0955-1016",
          "0955-1012",
          "0955-1015"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "ENOXAPARIN SODIUM"
        ],
        "rxcui": [
          "854228",
          "854235",
          "854238",
          "854241",
          "854245",
          "854248",
          "854252",
          "854255"
        ],
        "spl_id": [
          "48bacfb7-7152-45b1-a188-59c4a205f5b0"
        ],
        "spl_set_id": [
          "20635579-c92d-4f6c-a332-1096d51002f2"
        ],
        "package_ndc": [
          "0955-1003-01",
          "0955-1003-10",
          "0955-1004-01",
          "0955-1004-10",
          "0955-1006-01",
          "0955-1006-10",
          "0955-1008-01",
          "0955-1008-10",
          "0955-1010-01",
          "0955-1010-10",
          "0955-1016-01",
          "0955-1012-01",
          "0955-1012-10",
          "0955-1015-01",
          "0955-1015-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8NZ41MIK1O"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78637",
      "recalling_firm": "Sanofi-Aventis U.S. LLC",
      "address_1": "55 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "08807-1265",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed nationwide.",
      "recall_number": "D-0153-2018",
      "product_description": "Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis, U.S. LLC Bridgewater, NJ 08807, NDC 0955-1012-10",
      "product_quantity": "11,474 cartons of 10 syringes per carton",
      "reason_for_recall": "Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL",
      "recall_initiation_date": "20171205",
      "center_classification_date": "20180105",
      "termination_date": "20191011",
      "report_date": "20180117",
      "code_info": "Lot #: 7S572, Exp. 04/2019",
      "more_code_info": ""
    }
  ]
}