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Bacteria identified in Tylenol recall

By Parija Kavilanz, senior writer


NEW YORK (CNNMoney.com) -- The Food and Drug Administration confirmed Wednesday that the bacteria found at the Johnson & Johnson plant that produced the recalled children's medicines was Burkholderia cepacia, a bacteria often resistant to common antibiotics.

Johnson & Johnson first identified the bacteria to CNNMoney.com earlier in the day.

The company said that although the bacteria was found on some drums used by its vendor to transport the raw materials, those contaminated drums never reached the Fort-Washington, PA-plant that made the recalled drugs.

According to the Centers for Disease Control and Prevention (CDC), B. cepacia is the name for a group of bacteria that can be found in soil and water.

The CDC said B. cepacia poses little medical risk to healthy people. However, those with certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with B. cepacia.

The CDC also said that transmission of B. cepacia from contaminated medicines and devices has been reported in the past and that the bacteria has caused infections in hospitalized patients.

Johnson & Johnson (JNJ, Fortune 500) said that B. cepacia was found by a supplier to the factory that is operated by its McNeil division.

"Remaining drums from that lot were sent to us, all of which tested negative for bacteria. Samples of finished product also tested negative," said Johnson & Johnson spokesman Marc Boston.

However, the Food and Drug Administration's (FDA) 17-page FDA inspection report of the McNeil plant released Tuesday, said its review of seven vendor lots found some drums at the Fort Washington facility contaminated with B. cepacia.

An FDA official said, "To the agency's knowledge, no bacterially contaminated components were used in the manufacture of any of the recently recalled McNeill products. Also, testing done to date has not found bacteria in finished products."

"Still, the FDA felt there was the potential for contamination and that a recall of all of these products was prudent to protect the public health. Once again we advise that consumers not use these McNeil products at this time."

Johnson & Johnson could not immediately be reached for a response.

McNeil recalled some 50 children's versions of the non-prescription drugs on Saturday for quality concerns, including "tiny particles" in some of the products that the company said may be solidified product ingredients or manufacturing residue such as tiny metal parts.

The FDA said the recall affects some 1,500 "lots" of the drugs which were distributed both in the United States and internationally.  To top of page

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