Bacteria ID’d in Tylenol recall

Friday, May 7, 2010 @ 10:05 AM gHale


Bacteria found at the Johnson & Johnson plant that produced the recalled children’s medicines including Tylenol and Benadryl was Burkholderia cepacia, a bacteria often resistant to common antibiotics, said Food and Drug Administration officials.
Although the bacteria were 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, company officials said.
B. cepacia is the name for a group of bacteria found in soil and water, according to the Centers for Disease Control and Prevention (CDC).
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 transmission of B. cepacia from contaminated medicines and devices has occurred in the past and the bacteria have caused infections in hospitalized patients.
Johnson & Johnson said a supplier to the factory operated by its McNeil division found the B. cepacia.
“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 FDA’s 17-page inspection of the McNeil plant, said its review of seven vendor lots found some drums at the Fort Washington facility contaminated with B. cepacia.
“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,” an FDA official said.
“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.”
McNeil recalled 50 children’s versions of the non-prescription drugs on Saturday for quality concerns, including “tiny particles” in some of the products the company said may be solidified product ingredients or manufacturing residue such as tiny metal parts.



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