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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.
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