{
  "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": "Chicago",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA077789"
        ],
        "brand_name": [
          "CHLORHEXIDINE GLUCONATE"
        ],
        "generic_name": [
          "CHLORHEXIDINE GLUCONATE"
        ],
        "manufacturer_name": [
          "Xttrium Laboratories, Inc."
        ],
        "product_ndc": [
          "0116-2001"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CHLORHEXIDINE GLUCONATE"
        ],
        "rxcui": [
          "834127"
        ],
        "spl_id": [
          "0cf3f53a-1fe5-92d7-e063-6394a90a9e9d"
        ],
        "spl_set_id": [
          "34d15e72-8770-49dc-a514-d44ae4468a1e"
        ],
        "package_ndc": [
          "0116-2001-16",
          "0116-2001-04",
          "0116-2001-15",
          "0116-2001-05",
          "0116-2001-06",
          "0116-2001-07"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0301162001158"
        ],
        "unii": [
          "MOR84MUD8E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "77443",
      "recalling_firm": "Xttrium Laboratories Inc",
      "address_1": "415 W Pershing Rd",
      "address_2": "N/A",
      "postal_code": "60609-2788",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Natiowide",
      "recall_number": "D-0938-2017",
      "product_description": "Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only,  Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056, NDC 0116-2001-16",
      "product_quantity": "36,720 16 oz. glass bottles",
      "reason_for_recall": "CGMP Deviations",
      "recall_initiation_date": "20170601",
      "center_classification_date": "20170702",
      "termination_date": "20180219",
      "report_date": "20170712",
      "code_info": "1999CHG16MC-Lot number 704-201 (full lot # 704-1999-201), Exp 03/20  1999CHG16MC-Lot number 705-208 (full lot # 705-1999-208), Exp 04/20"
    }
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}