{
  "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": [
          "NDA021669"
        ],
        "brand_name": [
          "CHLORHEXIDINE GLUCONATE"
        ],
        "generic_name": [
          "CHLORHEXIDINE GLUCONATE"
        ],
        "manufacturer_name": [
          "Sage Products LLC"
        ],
        "product_ndc": [
          "53462-705"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CHLORHEXIDINE GLUCONATE"
        ],
        "rxcui": [
          "846127"
        ],
        "spl_id": [
          "45c31000-edfe-4387-e063-6394a90aeb61"
        ],
        "spl_set_id": [
          "bdb6a012-37e5-4664-84a3-134bea284744"
        ],
        "package_ndc": [
          "53462-705-20",
          "53462-705-23",
          "53462-705-26"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "MOR84MUD8E"
        ]
      },
      "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-0231-2017",
      "product_description": "2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC 3909 Three Oaks Road, Cary, Illinois 60013, NDC 53462-705-20.",
      "product_quantity": "2756 cases",
      "reason_for_recall": "CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.",
      "recall_initiation_date": "20160729",
      "center_classification_date": "20161222",
      "termination_date": "20190311",
      "report_date": "20161228",
      "code_info": "Lot #: a) 50749, Exp. 9/29/16; 50765, Exp. 9/30/16; 50771, Exp. 9/30/16; 50773, Exp. 10/01/16; 52839, Exp. 2/9/17; 52843, Exp. 2/9/17; 52855, Exp. 2/10/17; 52861, Exp. 2/10/17; 53840, Exp. 4/21/17; 56081, Exp. 9/1/17; 56513, Exp. 9/26/17; b) 54760, Exp. 6/15/17; c) 54763, Exp. 6/16/17  a)  Lot # 50749 , Exp. 9/29/2016 ;  Lot # 50765 , Exp. 9/30/2016 ;  Lot # 50771 , Exp. 9/30/2016 ;  Lot # 50773 , Exp. 10/1/2016 ;  Lot # 52839 , Exp. 2/9/2017 ;  Lot # 52843 , Exp. 2/9/2017 ;  Lot # 52855 , Exp. 2/10/2017 ;  Lot # 52861 , Exp. 2/10/2017 ;  Lot # 53840 , Exp. 4/21/2017 .    b)  Lot # 54763, Exp. 6/16/2017.    c)  Lot # 54760, Exp. 6/15/2017."
    }
  ]
}