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U.S. Department of Health and Human Services

Safety

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2007 MedWatch Safety Alert: Salivart Oral Moisturizer

The following information is from Gebauer Company. Contact the company for a copy of any referenced enclosures.


Gebauer Company Announces a Voluntary Recall of Salivart® Oral Moisturizer

CLEVELAND--(BUSINESS WIRE)--Gebauer Company, a 107-year-old medical device manufacturer and marketer, today announced a nationwide, voluntary firm initiated recall of certain lots of its Salivart Oral Moisturizer, product number 0386-0009-75. These lots may contain some units that do not meet the Company’s internal specification for aerobic microorganisms and mold.

The problem was discovered during routine stability testing. The problem is not uniform throughout the lots. Use of the affected units of these lots of Salivart Oral Moisturizer may cause temporary and reversible health problems such as nausea, vomiting, and diarrhea.

Lot numbers and expiration dates are located on the bottom of the product can. The recalled product lots are:

Lot Number Expiration Date Initial Ship Date
06AA001 06-08 09-11-06
06AA002 06-08 10-05-06
06AA003 06-08 10-26-06
06AA004 07-08 11-16-06
06AA005 07-08 12-14-06
06AA006 10-08 01-10-07

Customers who believe they are in possession of the recalled product should stop using the product and dispose of it immediately in their regular trash.

“We are committed to the quality of our products and we are taking all necessary measures to remedy this production issue,” said John Giltinan, President of Gebauer Company. “Salivart Oral Moisturizer has been used safely since 1990 and is supported by our history of meeting high safety and efficacy standards.”

Should customers require additional information, they are to contact Gebauer Company Customer Service at (800) 321-9348.

Contacts

Gebauer Company
Customer Service, 800-321-9348