Investigations on Tylenol recall from House Committee

By Dr. Ananya Mandal, MDMay 6 2010

Following the massive recall of children’s and infants’ fever medicine Tylenol and other over the counter drugs (like Motrin, Benadryl and Zyrtec) for children a congressional committee has urged an investigation into the problem.

According to Reps. Edolphus Towns (D-N.Y.) and Darrell Issa (R-Calif.), the leaders of the House Committee on Oversight and Government Reform, this is very grave because it affects approximately 70 percent of the market for over-the-counter pediatric liquid medicines. They plan to ask “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 hearing according to them can be expected in the next few weeks.

Food and Drug Administration (FDA) only this week revealed the papers that were compiled by federal inspectors on the quality control problems at the Pennsylvania unit where these recalled drugs were manufactured by McNeil Consumer Healthcare, a division of Johnson & Johnson. The inspectors at the McNeil plant in a 10-day “routine inspection” (Started on 19^th April) also found deficiencies in the quality control processes, manufacturing etc. There was a gross failure to track customer complaints, identify trends for serious adverse events or side effects, inappropriate personnel training and lack of written protocols. There were at least 46 consumer complaints since last June to last month. The plant failed to address these complains. There were “known contamination” of raw materials with unspecified bacteria said the inspectors. The FDA inspectors announced this Tuesday that these bacteria could not be identified. McNeil denied any contamination.

McNeil agreed that some of these drugs had more of the active ingredient while some had lower amounts or black particles. This was not according to international standards. On the last day of the inspection last Friday, McNeil itself announced the voluntary recall of 43 types of Tylenol and brand names made at the facility. It also suspended operations at the plant indefinitely. Johnson & Johnson said the plant wouldn't be reopened until “we have taken the necessary corrective actions and can assure the quality of products made there.”

This present investigation hopes to clarify these conflicting reports and get to the bottom of the issue. “FDA and McNeil Consumer Healthcare have given conflicting accounts of the circumstances surrounding the recall, including what prompted the recall and how serious the recall is,” the House committee said in a statement.