{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "49985",
      "product_res_number": "Z-0497-2007",
      "event_date_initiated": "2007-01-19",
      "event_date_posted": "2007-03-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-12-17",
      "res_event_number": "37150",
      "product_code": "LFD",
      "k_numbers": [
        "K981693"
      ],
      "product_description": "Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part Number:  0386-0009-75; Manufactured by Gebauer Company, Cleveland, Ohio",
      "code_info": "Lot ''06AA003'', expiration date 06/08 Lot ''06AA001'', expiration date 06/08 Lot ''06AA002'', expiration date 06/08 Lot ''06AA004'', expiration date 07/08 Lot ''06AA005'', expiration date 07/08 Lot ''06AA006'', expiration date 10/08 Lot ''06AA007'', expiration date 10/08",
      "firm_fei_number": "1519179",
      "recalling_firm": "Gebauer Company",
      "address_1": "4444 E 153rd St",
      "city": "Cleveland",
      "state": "OH",
      "postal_code": "44128",
      "additional_info_contact": "Amy Paukovits\n216-581-3030 Ext. 120",
      "reason_for_recall": "Microbial Contamination-certain lots of product failed USP <61> Microbial Limits Testing for total aerobic count during 6 month stability testing.",
      "root_cause_description": "Other",
      "action": "The recalling firm sent recall letters dated 1/23/2007 to their Distributor Customers and Non-distributor customers who received Salivart product from Lot Code: 06AA003. both letters include an attached recall response form which the customers are instructed to destroy the product, complete a form and fax back it to the recalling firm. The response forms provide verification that the form has been received by the customer(s). With the initiation of the RECALL EXPANSION for more lot codes to be recalled on 2/14/2007, the firm issued new recall letters dated, 2/13/2007, 2/15/2007 and 2/22/2007. These four letters provide the same basic information and also have attached recall response cards, however, they list  the additional 6 lot codes subject to recall. The firm issued a Press Release concerning this recall through Cleveland (Business Wire) on 3/1/2007.",
      "product_quantity": "34,545 cans",
      "distribution_pattern": "The product was distributed throughout the U.S. to wholesalers, retail accounts (i.e. pharmacies, dental offices, and medical facilities) and full size samples of product were given away at trade shows to medical, and dental offices and some end users consumers).  A total of 240 units of product derived from Lot Code: 06AA001, were distributed to a single Canadian distributor under the assigned Lot Code:  06BB002",
      "openfda": {
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          "K203567",
          "K981693",
          "K103745",
          "K163476",
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        ],
        "device_name": "Saliva, Artificial",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U",
        "pma_number": [
          "P790016"
        ],
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        "fei_number": [
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}