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FDA Found Bacteria in Ingredients for Recalled Tylenol, Benadryl
Date:5/4/2010

s were used to make finished products, Autor said. "The problems that we have actually seen in products that are on the market are ones that we do not believe will cause a significant medical concern," she said. "Based on what we have seen, we don't have concrete information to believe there is a serious medical concern."

Exactly what the bacteria is is not yet known, said Michael A. Chappell, acting associate commissioner for regulatory affairs. "I don't have that information," he said during the press briefing.

None of the finished products tested by the agency were positive for bacteria, he added.

Parents should discontinue use of the recalled products, and alternative products are available, FDA commissioner Dr. Margaret A. Hamburg said during news conference. She said that parents should not be unduly alarmed, since "the potential for serious health problems is remote."

According to Autor, the FDA is now evaluating the report and will decide if any regulatory action is needed. "The findings are serious, but we cannot say whether further action by FDA is warranted," she said.

More information

For more information on the recall, head to a special "What Consumers Need to Know" page at the U.S. Food and Drug Administration.



SOURCES: May 4, 2010, press teleconference with: Margaret A. Hamburg, M.D., Commissioner; Michael A. Chappell, Acting Associate Commissioner for Regulatory Affairs; Deborah M. Autor, director, Office of Compliance, Center for Drug Evaluation and Research all U.S. Food and Drug Administration


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