Recall Z-0497-2007 ยท LFD Saliva, Artificial
Gebauer Company
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
| Date | Mar 20, 2007 (initiated Jan 19, 2007) |
| Status | Terminated |
| Reason | Microbial Contamination-certain lots of product failed USP <61> Microbial Limits Testing for total aerobic count during 6 month stability testing. |
| Root cause | 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. |
| Quantity | 34,545 cans |
| Distribution | 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 der |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981693 | SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 Gebauer Co., Aug 6, 2001 |