{
  "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 II",
      "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",
          "53462-915-60"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      },
      "product_type": "Drugs",
      "event_id": "69141",
      "recalling_firm": "Sage Products Inc",
      "address_1": "3909 3 Oaks Rd",
      "address_2": "",
      "postal_code": "60013-1804",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1573-2014",
      "product_description": "Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 3909 Three Oaks Road, Cary, IL 60013",
      "product_quantity": "8-ct. 7,066 cases; 24-ct. 2,664 cases",
      "reason_for_recall": "Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.",
      "recall_initiation_date": "20140827",
      "center_classification_date": "20140903",
      "termination_date": "20160208",
      "report_date": "20140910",
      "code_info": "Lot: 44385; Exp.06/16; Lot: 44669; Exp.12/15",
      "more_code_info": ""
    }
  ]
}