Johnson & Johnson is voluntarily recalling 4 million
bottles of plaque-detecting Listerine for children after testing determined the
mouth rinse was contaminated by bacteria.
The company found that preservatives in the product didn't kill four types
of bacteria, said Meghan Marschall, a spokeswoman for McNeil PPC Inc., a J&J
unit. The recall involves a brand introduced last year called Agent Cool Blue
in flavors including Glacier Mint and Bubble Blast, the company said yesterday.
"There could be a significant risk to individuals with weakened or
depressed immune systems," Marschall said in a telephone interview yesterday.
The risk is low in healthy people and no adverse events have been reported, the
No other Listerine products are affected. The Agent Cool Blue brand tints
plaque on teeth blue to help children learn to brush their teeth more
effectively. NcNeil notified the FDA about the discovery last week, Marschall
The bacteria found included Klebsiella oxytoca, which can cause urinary
tract infections and blood poisoning; Serratia marcecens, linked to blood
stream infections; Enterobacter cloacae, tied to respiratory infections; and
Pseudomonas fluorescens, which is harmless to most people.
J&J acquired Listerine when the company agreed in November to buy Pfizer
Inc.'s consumer unit for $16.6 billion. J&J, maker of thousands of products
including Band-Aids and the painkiller Tylenol, also acquired Pfizer consumer
products such as the hair treatment Rogaine and Sudafed cold pills with the
purchase, which closed in January.
The problem with the preservative in Agent Cool Blue is "pervasive,"
Marschall said. She declined to say whether the company would permanently halt
sales of the rinse or reformulate it to prevent contamination in the future.
"We're focused on the recall and we're doing extensive outreach to the
dental community, retailers, pharmacists and making sure consumers are aware of
this," Marschall said.
It would be a shame for the product to not return to the market, said Mary
Hayes, a pediatric dentist in private practice in Chicago and a spokeswoman for
the American Dental Association. Young children often have trouble brushing
correctly, while adolescents have to deal with growing teeth and a changing
mouth shape that can affect their brushing, she said.
"I'm not aware of other things that are as easy to use as this," Hayes
said. "It's fun and goofy, and then they can clean it off. I like the concept
of products like this that help children visualize where they are missing."
Hayes said she will advise children and their parents to return their bottles
and quit using the product until the source of the problems are identified and
"We need a degree of caution," she said. "That doesn't mean the product in
the future will be bad."