{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Cary",
      "state": "IL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "COMFORT SHIELD BARRIER"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "Sage Products LLC"
        ],
        "product_ndc": [
          "53462-915"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "rxcui": [
          "968663",
          "1088604"
        ],
        "spl_id": [
          "419e18cd-fa52-b78d-e063-6294a90a467c"
        ],
        "spl_set_id": [
          "cc08f571-84ae-4c2f-b09d-a83a8efc39f5"
        ],
        "package_ndc": [
          "53462-915-50",
          "53462-915-51",
          "53462-915-62",
          "53462-915-80",
          "53462-915-81",
          "53462-915-24",
          "53462-0915-62"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      },
      "product_type": "Drugs",
      "event_id": "74819",
      "recalling_firm": "Sage Products LLC",
      "address_1": "3909 3 Oaks Rd",
      "address_2": "N/A",
      "postal_code": "60013-1804",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.",
      "recall_number": "D-0229-2017",
      "product_description": "COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80;   c)  24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.",
      "product_quantity": "576,802 cases total for product codes 7503, 7905, and 7526",
      "reason_for_recall": "Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.",
      "recall_initiation_date": "20160729",
      "center_classification_date": "20161222",
      "termination_date": "20190311",
      "report_date": "20161228",
      "code_info": "Lot #: a) 53957, Exp 03/06/18; b) 54769, Exp 04/22/18; 54922, Exp 05/03/18; 55781, Exp 06/19/18; c) 53095, Exp 07/13/17"
    }
  ]
}