The Johnson and Johnson unit that voluntarily recalled certain lots of children’s liquid Tylenol and Motrin over the weekend had numerous and wide-ranging quality control problems at the plant that made the products, according to a federal inspection report released Tuesday and reported in the New York Times.
That unit, McNeil Consumer Healthcare, failed to adequately investigate and correct various deficiencies in its manufacturing and drugs made at its plant in Fort Washington, Pa., according to the report, posted Tuesday afternoon on the Web site of the Food and Drug Administration.
“This is yet another example of the need for companies to take full accountability for the quality of their drugs, and the serious consequences that can happen when companies do not do so,” said Deborah M. Autor, the director for compliance at the agency’s Center for Drug Evaluation and Research.
The report, which the agency had sent to McNeil last Friday, before the recall, said the company had used raw materials with known bacterial contamination to make certain lots of infants’ and children’s liquid Tylenol.
Samples of finished products tested negative for bacteria, however, and the risk to consumers was remote, agency officials said.