April 27, 2006 — /FDA News/ — Bellevue, Wash. — Pascal Company, Inc., located in Bellevue, Washington, is recalling all lots and all flavors of their products, NeutraGard 0.05% Neutral Sodium Fluoride Anticavity Treatment Rinse and NeutraGard Plus 0.2% Neutral Sodium Fluoride Anticavity Treatment Rinse, all flavors (Mint and Tropical Blast) packaged in clear 16 oz plastic bottles because they may be contaminated with bacteria called Burkholderia cepacia and Pseudomonas aeruginosa.
The organism, Burkholderia cepacia poses little medical risk to healthy people. However, people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis (CF), may be more susceptible to infections with B. cepacia. B. cepacia is a known cause of infections in hospitalized patients. The effects of B. cepacia on people vary widely, ranging from no symptoms at all, to serious respiratory infections, especially in patients with CF.
The organism, Pseudomonas aeruginosa may cause urinary tract infections, respiratory system infections, dermatitis, soft tissue infections, bacteremia, bone and joint infections, gastrointestinal infections and a variety of systemic infections, particularly in patients with severe burns and in cancer and AIDS patients who are immunosuppressed. Pseudomonas aeruginosa infection is a serious problem in patients hospitalized with cancer, cystic fibrosis, and burns.
Pascal Company, Inc. has initiated a recall to the consumer level. Approximately 55,000 bottles were distributed worldwide since 2001 to dental wholesalers, who in turn distributed the products to dental offices. These products were not available at any retail outlets or pharmacies.
The problem was discovered during recent testing of samples stored for long-term studies conducted after the products were distributed. Only a small number of batches produced since 2001 showed the presence of these organisms, primarily in batches distributed prior to 2005. A majority of batches tested negative for the presence of these organisms. However, because Pascal Co., Inc. did not test all batches, the company has decided to issue a recall for all batches distributed since 2001.
Consumers and dental offices that have the product should discontinue use of the product and destroy it immediately, or return it to their place of purchase for further processing. Consumers with questions regarding the recall may contact Pascal Company, Inc. at 800-426-8051, or go to http://www.pascaldental.com, and click on the NeutraGard Rinse recall link. This recall is being made in cooperation with the U.S. Food and Drug Administration.
Any adverse reactions experienced with the use of this product should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at http://www.fda.gov/medwatch.