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.
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."
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.
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