FDA Found Bacteria in Ingredients for Recalled Tylenol, Benadryl

Agency also cited maker Johnson & Johnson for 'numerous deficiencies' at plant

May 4, 2010

(HealthDay News) -- Bacterial contamination has been found in ingredients used to make the liquid cold and allergy products for children that were recalled Friday by drug giant McNeil Consumer Healthcare, according to a report issued late Tuesday by the U.S. Food and Drug Administration.

Last Friday, McNeil initiated a voluntary recall of more than 40 products, including liquid Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl. These medications have been sold in the United States and 11 other countries. In all, about 1,500 lots of these products have been recalled.

The company also closed its plant in Fort Washington, Pa., where the contaminated products were made. The plant remains closed and cannot reopen without FDA approval.

Speaking at a Tuesday afternoon press briefing, Deborah M. Autor, director of the FDA's Office of Compliance, Center for Drug Evaluation and Research, said that in February, the agency met with executives of McNeil Healthcare and its corporate parent Johnson & Johnson to complain about the company's manufacturing practices.

McNeil had received 46 consumer complaints of foreign substances in its products, the FDA said.

In mid-April, the FDA began its inspection of the plant and found "numerous deficiencies in the way products were manufactured and the way the manufacturing process for those products was controlled," Autor said. The inspection process finished Friday.

These deficiencies included poor manufacturing practices and failure to maintain proper facilities and procedures for testing drugs, Autor said.

According to the agency report, some of the raw materials used to make products such as liquid Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl were found to be contaminated with as yet-unknown bacteria.

In turn, these raw materials 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 the 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.

SOURCES: May 4, 2010, press teleconference with Margaret A. Hamburg, M.D., commissioner, Michael A. Chappell, acting associate commissioner for regulatory affairs, and Deborah M. Autor, director, Office of Compliance, Center for Drug Evaluation and Research, all with the U.S. Food and Drug Administration

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