Grime, bacteria in plant of recalled drugs

May 6, 2010 at 12:17 AM
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WASHINGTON, May 6 (UPI) -- The U.S. Food and Drug Administration identified the bacteria found at the plant where dozens of recalled children's medications were manufactured.

FDA officials said Burkholderia cepacia was the bacteria found in soil and water -- often resistant to common antibiotics -- found in the McNeil Consumer Healthcare plant in Fort Washington, Pa., a division of Johnson & Johnson.

However, the company said although the bacteria were found on some drums used by its vendor to transport the raw materials, those contaminated drums never reached the Fort Washington plant, reported.

A Johnson & Johnson spokesman said the remaining drums sent by a supplier tested negative for the bacteria and samples of finished product also tested negative, said.

However, the FDA inspection report said some drums at the Fort Washington facility were contaminated with B. cepacia and there is a potential of contamination.

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

This week more than 40 over-the-counter and prescription drugs such as Children's Tylenol, Infants' Tylenol and Children's Motrin were voluntarily recalled.

"We have temporarily suspended production at our Fort Washington, Penn., plant, where the observations were made," a statement by McNeil Consumer Healthcare regarding the FDA inspection report said.

"We will not restart operations until we have taken the necessary corrective actions and can assure the quality of products made there."

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