Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part Number: 0386-0009-75; Manufactured by

FDA device recall Z-0497-2007 · posted 2007-03-20 · Terminated

Recall details

Recalling firm

Gebauer Company

Reason for recall

Microbial Contamination-certain lots of product failed USP <61> Microbial Limits Testing for total aerobic count during 6 month stability testing.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

LFD

Quantity affected

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 show

Date initiated

2007-01-19

Date posted

2007-03-20

Date terminated

2007-12-17

Location

Cleveland, OH

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