{
  "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": "Ongoing",
      "city": "Bridgewater",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA209196"
        ],
        "brand_name": [
          "ADMELOG"
        ],
        "generic_name": [
          "INSULIN LISPRO"
        ],
        "manufacturer_name": [
          "Sanofi-Aventis U.S. LLC"
        ],
        "product_ndc": [
          "0024-5924",
          "0024-5925",
          "0024-5926"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "INSULIN LISPRO"
        ],
        "rxcui": [
          "242120",
          "1652639",
          "1992169",
          "1992171"
        ],
        "spl_id": [
          "9631cc90-ea8d-42bb-ba01-ed8f09b8a6c5"
        ],
        "spl_set_id": [
          "0691def8-4a7b-4de3-866f-a280989f47f1"
        ],
        "package_ndc": [
          "0024-5924-10",
          "0024-5925-01",
          "0024-5925-05",
          "0024-5925-00",
          "0024-5926-05"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000004931",
          "N0000175453"
        ],
        "pharm_class_cs": [
          "Insulin [Chemical/Ingredient]"
        ],
        "pharm_class_epc": [
          "Insulin Analog [EPC]"
        ],
        "unii": [
          "GFX7QIS1II"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80387",
      "recalling_firm": "Sanofi-Aventis U.S. LLC",
      "address_1": "55 Corporate Dr",
      "address_2": "",
      "postal_code": "08807-1265",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0925-2018",
      "product_description": "Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0024-5925-00",
      "product_quantity": "3214 prefilled pens",
      "reason_for_recall": "Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.",
      "recall_initiation_date": "20180705",
      "center_classification_date": "20180716",
      "report_date": "20180718",
      "code_info": "Lot #: 7F021B, Exp 6/30/20",
      "more_code_info": ""
    }
  ]
}