FDA warning - moldy oral swabsticks

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Recall -- Firm Press Release

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Kingswood Laboratories, Inc. Issues Nationwide Recall of Moi-Stir Oral

Swabsticks

Contact:

Kingswood Laboratories, Inc.

Suchinda Stithit, R.Ph., Ph.D.

1-800-968-7772

FOR IMMEDIATE RELEASE --Indianapolis, IN -- April 22, 2005 --- Kingswood

Laboratories, Inc., Indianapolis, IN, is initiating a nationwide recall of

Moi-Stir Oral Swabsticks. Some of the swabsticks have been found to contain

molds including Aspergillus and Penicillium which could result in respiratory

infections.Consumers who have any of the recalled Moi-Stir Swabsticks should

stop using them immediately and return them to the point of purchase.

Doctors and dentists should consider screening patients who are at risk for

infections, especially those with weakened immune systems (low white blood cell

counts) who have used the Moi-Stir Swabstick.

Moi-Stir Swabsticks are oral swabs used to moisten the mouths of patients.

Moi-Stir is a saliva supplement intended to relieve dry mouth, physically clean

the oral cavity, thin phlegm, and lower dental caries rates. The product was

distributed to hospitals, hospital wholesalers, pharmacies, nursing homes,

physician and dentist offices, consumers, some government medical facilities,

and as free samples to a small number of individuals. The swabsticks are

packaged as three sticks in a white foil pouch, with " Moi-Stir " on the front of

the pouch, in green lettering.

The recall includes Moi-Stir Swabsticks with lot numbers A2, 1193, 1209, 1233,

1260, and 1725. Lot numbers are marked on each case, carton, and individual

pouch of swabs. (The lot number for A2 is embossed into the right side of the

pouch. All other lot number's are embossed into the pouch, at the bottom right

corner.) No expiration dates are included in the labeling.

The firm voluntarily recalled the products after learning of this problem. FDA

has been apprised of this action.

No injuries have been reported to date.

Kingswood Laboratories, Inc. is notifying its distributors and customers by

phone, fax, and e-mail and is arranging for the immediate return of all recalled

product.

Consumers and healthcare professionals with questions may contact Lynn Meng, RN,

MSN, Quality Assurance Manager or Suchinda Stithit, R.Ph., Ph.D., Director of

Regulatory Affairs, Kingswood Laboratories, Inc. at 1-800-968-7772 between the

hours of 8:30 AM and 5:00 PM, Monday through Friday.