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

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

TUESDAY, May 4 (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 material
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