MORRIS PLAINS, NEW JERSEY – April 11, 2007 ? McNEIL-PPC, Inc. (the “Company”) today announced a voluntary nationwide consumer recall of all lots of the BUBBLE BLAST? flavors of ? Plaque-Detecting Rinse after the Company determined that the preservative system is not adequate against certain microorganisms.McNEIL-PPC, Inc. has been in full communication with the FDA regarding this issue and the decision to implement a voluntary recall.? and
Have other countries been impacted or just the U.S.?
The Caribbean: Specifically Puerto Rico, Antigua, Bahamas, Belize, Bermuda, Cayman Islands, Grenada, Guyana, Jamaica, Haiti, Netherlands Antilles, St. Lucia, St. Kitts, St. Vincent, Suriname, Trinidad
The Company conducted a thorough assessment and concluded that the risk of illness in healthy individuals following use of this product is very low. However, there could be a significant health risk to individuals with weakened or suppressed immune systems. To date, there have been no consumer adverse health events reported that are related to this issue.
“We have voluntarily initiated this recall of ? Plaque-Detecting Rinse because our primary concern is that consumers have complete confidence in the safety and effectiveness of our products,” said Paul Sturman, President, Consumer Healthcare North America, McNEIL-PPC, Inc. “This voluntary action is in keeping with our longstanding policy of providing timely and effective consumer information about all our products.“
? Plaque-Detecting Rinse has been sold to consumers through supermarkets, drug stores, mass merchants and other retail outlets, and is sold to dental professionals’ offices nationwide. The Company is contacting dental professionals and retailers directly as part of their recall notification process.