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U.S. Department of Health and Human Services

Safety

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NeutraGard 0.05% and NeutraGard Plus 0.2% Neutral Sodium Fluoride Anticavity Treatment Rinse

Audience: Dentists, dental hygienists, and consumers
[Posted 04/28/2006] Pascal Company, Inc. recalled all lots and all flavors of NeutraGard 0.05% Neutral Sodium Fluoride Anticavity Treatment Rinse and NeutraGard Plus 0.2% Neutral Sodium Fluoride Anticavity Treatment Rinse packaged in clear 16 oz plastic bottles. The products were recalled because they may be contaminated with Burkholderia cepacia and Pseudomonas aeruginosa bacteria.

Burkholderia cepacia (B. cepacia) bacteria poses little medical risk to healthy people. However, the bacteria may affect individuals with certain health problems like a weakened immune system or chronic lung diseases, such as cystic fibrosis. The effects of B. cepacia range from no symptoms to serious respiratory infections, especially in patients with cystic fibrosis.

Pseudomonas aeruginosa may cause urinary track 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.

Dental offices and consumers who have the product should discontinue use and destroy it or return the product to the place of purchase for further processing.

[April 27, 2006 - Recall Notice - Pascal Company, Inc.]