Rep. Edolphus "Ed" Towns, D-N.Y., chairman of the House Committee on Oversight and Government Reform, and Rep. Darrell Issa, R-Calif., the ranking minority member, said in a statement they are seeking clarification of information about the significance of contamination of the medications by raw materials.
Last week McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, recalled more than 40 over-the-counter and prescription drugs such as Children's Tylenol, Infants' Tylenol and Children's Motrin.
Towns and Issa said the U.S. Food and Drug Administration and McNeil have given conflicting accounts about how the recall came about, including what prompted it and how serious it is.
Noting it is the third recall of Tylenol products in less than a year, the lawmakers said they also are questioning the adequacy of the FDA's inspection procedures and whether McNeil failed to investigate consumer complaints that could have identified the problems.
"We are deeply concerned about the recall of popular pediatric medications widely used by infants and children across the country," Towns and Issa said. "When a recall of this nature occurs, it is our responsibility to bring attention to the issue as a public service and to fulfill our oversight responsibility by asking tough questions about the conditions of the manufacturing plant and controls put in place by the drug company's management, and about whether FDA's inspection and recall procedures were sufficient."
The Washington Post reported the congressional probe comes a day after the FDA released documents cataloguing widespread quality-control problems at the Pennsylvania plant where the recalled medicines were made.